(115 days)
Not Found
No
The provided text does not mention AI, ML, DNN, or image processing, and the device description focuses on standard physiological monitoring modules.
No
The device is a monitor intended for measurement and monitoring of physiological parameters (carbon dioxide concentration, respiration rate, oxygen saturation, and pulse rate), not for delivering therapy.
Yes
Explanation: The device is intended for "continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate)." This involves measuring physiological parameters to provide information for diagnosis or monitoring a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "bedside monitor" consisting of hardware modules (EtCO2 MiniMediCO2 module, MP100 SpO2 module) and displays and alarms, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Capnostream20 and Capnostream10 devices are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- The Capnostream devices are described as monitoring devices that perform continuous, non-invasive measurements of physiological parameters directly from the patient (carbon dioxide concentration of expired/inspired breath and oxygen saturation). They do not analyze samples taken from the body.
Therefore, the function and intended use of the Capnostream devices fall outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
The Capnostream10 is intended for CO2 indications only. The Capnostreamso is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and insoired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
Product codes
73CCK, DQA
Device Description
The Capnostream20 bedside monitor is a two parameter monitor consisting of an EtCO2 MiniMediCO2 module and a MP100 SpO2 module, displays and alarms.
The Capnostream20 Bedside Monitor is comprised of two modules used in previously FDA cleared devices with the following indications for use, which together are the indications for use for the two parameter bedside monitor:
- The MiniMediCO₂ EtCO₂ Module: Is intended for installation in host devices that: are used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal Intensive care and other health care areas where non invasive measurement of expired CO2 and inspired CO2 are of medical value. It continuously and non invasively measures and monitors carbon dioxide concentration of the expired and inspired breath and respiration rate. This module is designed to be installed in a host device, in this case the two Parameter Bedside Monitor, that is for prescription use only.
- The MP100 Oximetry Module: Is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused. It is to be used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal Intensive care and other health care areas. This module is designed to be installed in a host device, in this case the two Parameter Bedside Monitor, that is for prescription use only.
The Capnostream ( bedside monitor is a one parameter monitor consisting of a MP100 EtCO2 module displays and alarms.
The Capnostream10 Bedside Monitor contains a MinMediCO2 EtCO2 module used in previously FDA cleared devices with the following indications for use.
The MiniMediCO2 EtCO2 Module: Is intended for installation in host devices that: are used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology. intensive care medicine, neonatal Intensive care and other health care areas where non invasive measurement of expired CO2 and inspired CO2 are of medical value. It continuously and non invasively measure and monitor carbon dioxide concentration of the expired and inspired breath and respiration rate. This module is designed to be installed in a host device, in this case the one Parameter Bedside Monitor, that is for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric and adult
Intended User / Care Setting
professionally trained health care providers, hospitals, hospital type facilities, intra hospital moves and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040011, K050844, K051608, K012891, K021090, K022084
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
K060065-Reply to FDA Letter of March 2, 2006
10.1.3.2. 510(k) Summary of Safety and Effectiveness Information Capnostreamon and Capnostream
510(k) Summary of Safety and Effectiveness Information Capnostream20 and Capnostream10
(This document is not confidential)
DATE THIS SUMMARY WAS PREPARED
March 20, 2006
SUBMITTERS NAME AND ESTABLISHMENT ADDRESS:
Oridion Capnography Inc.
21 Highland Circle
Needham, MA 02494-3038
PRODUCT NAMES
NOTE: This summary statement is for a bundled submission and covers the Capnostream20 and Capnostream 10
Capnostream20
Proprietary: Capnostream20
Common: Two Parameter Bedside Monitor
Capnostream 10
Proprietary: Capnostream10
Common: One Parameter Bedside Monitor
ESTABLISHMENT REGISTRATION NUMBER
Establishment Registration Number: 3003941644
CONTACT PERSON:
Sanford Brown, Regulatory Affairs Director
Oridion Medical 1987 Ltd.
Har Hotzvim Science Based Industrial Park
POB 45025
91450 Jerusalem, Israel
Telephone: +972-2-589-9115
FAX: +972-2-586-6680
1
B051971
DEVICE DESCRIPTIONS
ళ్ళ Capnostream20
The Capnostream20 bedside monitor is a two parameter monitor consisting of an EtCO2 MiniMediCO2 module and a MP100 SpO2 module, displays and alarms.
SUBSTANTIAL EQUIVALENCE INFORMATION
- · CO2 Module (MiniMediCO2) used in legally marketed Predicate Devices:
- Pulse Oximeter Module, SpO2 Module (MP100) used in legally marketed Predicate . Devices:
- Nurse Call .
CLASSIFICATION
Capnostream20
73CCK Class II
This device has two modules that are classified as follows:
- 21 CFR 868.1400, carbon dioxide analyzer .
- . 21 CFR870.2700 Pulse Oximeter
INTENDED USE
The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
Oridion Medical 1987 Ltd.
2
DEVICE DESCRIPTION
The Capnostream20 Bedside Monitor is comprised of two modules used in previously FDA cleared devices with the following indications for use, which together are the indications for use for the two parameter bedside monitor:
Capnostream20
1. The MiniMediCO₂ EtCO₂ Module:
ls intended for installation in host devices that: are used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal Intensive care and other health care areas where non invasive measurement of expired CO2 and inspired CO2 are of medical value. It continuously and non invasively measures and monitors carbon dioxide concentration of the expired and inspired breath and respiration rate. This module is designed to be installed in a host device, in this case the two Parameter Bedside Monitor, that is for prescription use only.
2. The MP100 Oximetry Module
ls indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused. It is to be used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal Intensive care and other health care areas. This module is designed to be installed in a host device, in this case the two Parameter Bedside Monitor, that is for prescription use only. .
Capnostream10 જુન
Capnostream 10
Proprietary: Capnostream10 Common: One Parameter Bedside Monitor
ESTABLISHMENT REGISTRATION NUMBER
Establishment Registration Number: 3003941644
CONTACT PERSON:
Sanford Brown, Regulatory Affairs Director
Oridion Medical 1987 Ltd.
Har Hotzvim Science Based Industrial Park
POB 45025
91450 Jerusalem, Israel
3
Confidential
FAX: +972-2-586-6680
DEVICE LISTING FDA FORM 2892:
B051971
DEVICE DESCRIPTION
The Capnostream ( bedside monitor is a one parameter monitor consisting of a MP100 EtCO2 module displays and alarms.
SUBSTANTIAL EQUIVALENCE INFORMATION
CO2 Module (MiniMediCO2) used in Predicate Devices: .
- ✓ Oridion Polaris 2004, K040011.
-
CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO2-V1 K050844
-
Larsen & Toubro Limited Star 50 Monitoring System K051608
CLASSIFICATION
Capnostream10
73CCK Class II
This device is classified as follows:
- . 21 CFR 868.1400, carbon dioxide analyzer
INTENDED USE
The Capnostream o is intended for CO2 indications only. The Capnostream10 is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
4
DEVICE DESCRIPTION
The Capnostream10 Bedside Monitor contains a MinMediCO2 EtCO2 module used in previously FDA cleared devices with the following indications for use.
The MiniMediCO2 EtCO2 Module:
ls intended for installation in host devices that: are used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology. intensive care medicine, neonatal Intensive care and other health care areas where non invasive measurement of expired CO2 and inspired CO2 are of medical value. It continuously and non invasively measure and monitor carbon dioxide concentration of the expired and inspired breath and respiration rate.
This module is designed to be installed in a host device, in this case the one Parameter Bedside Monitor, that is for prescription use only.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.
MAY - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oridion Capnography, Incorporated C/O Mr. Stanford Brown Regulatory Affairs Director Oridion Medical 1987 Limited Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel
Re: K060065
Trade/Device Name: Capnostream20 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 6, 2006 Received: April 7, 2006
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
10.1.3.1. Indications for Use
Two Parameter CAPNOSTREAM20 Monitor and Single Parameter Capnostream10 Monitor
(This document is not confidential)
Indications for Use
March 20, 2006
510(k) Number (if known)
Device Name: Capnostream20
Indications For Use:
The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
Device Name: Capnostream10
Indications For Use:
The Capnostream10 is intended for CO2 indications only. The Capnostreamso is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and insoired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________, and the 510(k) number is K060065. The signature is also not included in the table. The Oridion Medical 1987 Ltd. text is also misplaced. The page number is also not included in the table. The corrected html is as follows: