(260 days)
No
The summary describes a standard vital signs monitor with no mention of AI or ML capabilities. The focus is on basic physiological parameter monitoring and data storage.
No
The device is described as a "handheld vital signs monitor" and is intended "for monitoring only." It gathers data on physiological parameters (EtCO2, RR, SpO2, pulse rate) but does not provide any therapy or treatment.
No
Explanation: The device is explicitly stated to be "for monitoring only" and gathers vital signs data without providing diagnoses or interpretations of the data to identify a specific disease or condition.
No
The device description explicitly states that the product is composed of a monitor, sensors, charging base, and USB adapter, in addition to PC software. This indicates the presence of significant hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states "monitoring only" of physiological parameters (EtCO2, RR, SpO2, PR) directly from the patient. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description focuses on the monitoring capabilities and the components used for direct patient measurement (sensors). There is no mention of analyzing biological samples.
- Lack of IVD-related terms: The document does not use terminology typically associated with IVDs, such as "specimen," "reagent," "assay," "analyte," or "laboratory."
- Anatomical Site: The anatomical site mentioned is the "Arteriolar bed," which is where SpO2 is measured directly on the patient, not a site from which a specimen is collected for in vitro analysis.
The device is a vital signs monitor that performs non-invasive measurements directly on the patient. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only. The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.
Product codes
DQA, CCK
Device Description
NTID Vital Signs Monitor provides:
- SpO2 monitoring
- Pulse rate (PR) monitoring
- End tidal carbon dioxide (EtCO2) monitoring
- Respiration rate (RR) monitoring
- CO2 and SpO2 waveform display
- Audible and visual physiological and technical alarms
- Trend graph and trend table review
- Alarm event records review
- History data storage
- Rechargeable batteries
- External power supply and charger
The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals.
The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.
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
adult and pediatric patients
Intended User / Care Setting
clinical environments where healthcare is provided by healthcare professionals, including hospital and hospital-type facilities.
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)
Clinical trial was conducted on NTID with T400A sensor. The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO9919:2005 Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for the medical use on ten healthy volunteers, in Hypoxia Research Laboratory, University of California, San Francisco.
It is notable that for the T400A-160108 sensor, over half (60%) of the individual subjects, the sensors performed with ARMS 3.0%, discussed in detail as requested) nevertheless meets the stated accuracy claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy:
For 70%-80%: ± 2%
For 80%-90%: ± 2%
For 90%-100%: ± 2%
For 70%-100%: ± 2%
Pulse Rate Accuracy: ±1bpm or ±2% (take the larger one)
EtCO2 Accuracy:
±2 mmHg (040mmHg)70mmHg)
±5% of reading (41
±8% of reading (71100mmHg)150mmHg)
±10% (101
Respiratory Rate Accuracy: ±1bpm
Predicate Device(s)
K032971, K073249, K042601, K053174
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Exhibit#3 510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92
1.0 Submitter's Information
Establishment Registration Name:
NEWTECH, INC
6th Industrial Road, NO. 1 Chuangye Dasha, Building C Nanshan District, Shenzhen Guangdong, 518067, P.R.CHINA
Contact Person of applicant
Ms. Zhou yanping & Mr. Chen Siping
Certification Dept. Manager
Tel: +86-755-26525910 Fax: +86-755-2652912 Email: chensp@sznewtech.com
Contact Person of the Submission:
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd .O. Box 237-023 Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Device Information 2.0
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Pulse Oximeter and carbon dioxide detector |
| Trade Name: | NT1D Vital Signs Monitor |
| Model: | NT1D |
| Classification name: | Oximeter |
AUG 27 2013
1
| Product Code: | DQA |
|---|---|
| Secondary Product Code | CCK |
| Classification: | Class II |
| Regulation Number | 21 C.F.R. 870.2700 |
3.0 Predicate Device Information
-
- TidalWave SP pulse oximeter / carbon dioxide monitor Models 710/715 (510(k)
No. K032971), dated 8/26,2004 .
- TidalWave SP pulse oximeter / carbon dioxide monitor Models 710/715 (510(k)
-
- SOLARIS NT1 and NT1A Handheld Pulse Oximeter with sensor accessories (510(k) No. K073249), dated 7/25,2008
Device description 4.0
NTID Vital Signs Monitor provides:
-
- SpO2 monitoring
-
- Pulse rate (PR) monitoring
-
- End tidal carbon dioxide (EtCO2) monitoring
-
- Respiration rate (RR) monitoring
-
- CO2 and SpO2 waveform display
- ••• Audible and visual physiological and technical alarms
-
- Trend graph and trend table review
-
- Alarm event records review
-
- History data storage
-
- Rechargeable batteries
-
- External power supply and charger
The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals.
The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.
产 SpO2 theory of operation
.
Pulse oximetry is based on two principles: (1).The oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (i.e. Spectrophotometry), and (2). The volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (i.e. plethysmography). A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption
2
during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LEDs) in the oximetry probe serve as light sources; a photodiode serves as the photo detector.
Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation .To identify the oxygen saturation of arterial bemoglobin, the monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood volume and light absorption increase.
During diastole, blood volume and light absorption reach their lowest point . The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption (i.e., Measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.
The Pulse oximeter determines SpO2 and pulse rate by passing two wavelengths of light, one red and one infrared, through body tissue to a photodetector. During measurement, the signal strength resulting from each light source depends on the color and thickness of the body tissue, the probe placement, the intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying effects of the pulse) in the body tissue. (Refer To Figure E3-1)
Image /page/2/Figure/5 description: This image shows a diagram of an Oxi-Pulse device. The diagram shows an LED and infrared LED light source, a detector, and a pulse bar graph. The Oxi-Pulse device measures 96% Sp02 and 72 pulse.
Figure E3-1: SpO2 Theory of Operation
The Pulse Oximeter processes these signals, separating the time invariant parameters (tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters (arterial volume and SpO2) to identify the pulse rate and calculate oxygen saturation. Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood.
A CO2 theory of overation
CO2 monitoring is to monitor the respiration of a patient by detecting the concentration of CO2 generated during respiration. The maximum concentration of CO2 at the end of exhalation is called End-Tide CO2 (EtCO2). The minimum concentration of CO2 at the end of inspiration is called Inspiration CO2 (FiCO2). CO2 is generated by cells in the body during metabolizing, and is breathed out via breathing system. The concentration of CO2 breathed out from the lung reflects directly the situation of metabolizing and breathing system. If the concentration of CO2 is high, it means that
3
metabolism is over active, such as blood poisoning or acute fever. If the concentration of CO2 is low, it is commonly due to a weak output ability of the heart, or the heartbeat stopped, or insufficient blood flow with less oxygen. Monitoring CO2 is used to warn the doctor of the abnormal breathing and metabolizing during anaesthesia.
The measurement value of CO2 is represented by a pressure level, with the unit: "mmHg" or "%". Generally, the maximum acceptable value is 38mmHg (5%) when air pressure is 760mmHg. The concentration of CO2 varies rapidly from 0% to 5%. To detect the concentration of CO2 accurately, the monitor needs to be very sensitive.
The monitor is used to measure EtCO2 and respiration rate of adult and pediatric patients.
5.0 Intended Use
NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO>), respiratory rate (RR), oxvgen saturation (SpO2), and pulse rate. The unit is intended for monitoring only. The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.
6.0 Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent(SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards.
| No | Description |
|---|---|
| 1 | IEC60601-1:1988+A1:1991+A2:1995 |
| Medical electrical equipment-Part1: General requirements for basic safety | |
| and essential performance | |
| 2 | IEC 60601-1-2: 2007 |
| Medical equipment-Part1-2: General requirements for safety-Collateral | |
| standard: Electromagnetic compatibility-Requirements and tests | |
| 3 | ISO 9919:2005 |
| Medical electrical equipment - Particular requirements for the basic safety | |
| and essential performance of pulse oximeter equipment for medical use | |
| 4 | ISO 21647:2004 |
| Medical electrical equipment - Particular requirements for the basic safety | |
| and essential performance of respiratory gas monitors. (Anesthesia) | |
| 5 | FCC CFR 47 Part 15 Part C |
| Radio frequency devices |
4
Comparison to predicate device and conclusion 7.0
The proposed device NT1D vital signs monitor is substantially equivalent to systems marketed predicate devices. The intended use of NTID vital signs monitor is same to TidalWave SP pulse oximeter. The design, the technological characteristics and the energy source are similar to TidalWave SP pulse oximeter. The comparison of technological characteristics between the proposed device and the predicate device in following table. Then NTID has two parts, one is SpO2 part, the other is CO2 part. The SpO2 part pulse oxygen sensor has three types, that is S400A .S400P and T400A. S400A and S400P are the finger sensors of the predicate device NT1/NT1A which numbered K073249. The SpO2 accuracy of NTID is same as NT1&NTIA.The CO2 part is provided by Respironics Novametrix , which has gotten 510(k) No. The mainstream CO2 sensor is Capnostat 5 CO2 Sensor, which 510(k) No. is K042601. The sidestream CO2 sensor is LOFlo C5 CO2 Sensor, which 510(k) No. is K053174. The notable difference between the NTID and the predicate device is wireless transmission fuction. About this function, NT1D does the FCC test, and the test result is pass, which confirmed that it will no effect on performance.
Table E3-1 Comparison of the technological characteristics between the proposed device and the predicate device.
| Comparison
Section | NT1D Vital Signs Monitor | TidalWave SP
pulse oximeter / carbon dioxide
monitor (Models 710/715) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NEWTECH, INC | Respironics Novametrix, Inc |
| 510(k) Number | Pending | K032971 |
| Intended Use | The Newtech NTID is a handheld
vital signs monitor that
continuously monitors end tidal
carbon dioxide (EtCO2),
respiratory rate (RR), oxygen
saturation (SpO2), and pulse rate.
The unit is intended for
monitoring only. The unit | The intended use of the Tidal Wave SP
(Models 710/715) is to provide short
term monitoring of carbon dioxide and
oxygen saturation during anesthesia /
recovery, in the intensive care unit
(ICU), and in Emergency Medicine
/Transport or Respiratory care.
Separate airway adapters are provided |
| transfers history data to PC for | | pediatric/adult and |
| through a USB adapter. It is for | | neonatal/pediatric use. The TidalWave |
| use in any environment where | | SP (Models 710/715) and its airway |
| continuous, noninvasive | | adapters and sensors are intended to |
| monitoring of these parameters is | | be used by trained operators when |
| desired, including hospital and | | capnographic and/or pulse oximetry |
| hospital-type facilities. The | | monitoring is required in the |
| monitor is intended for use on | | judgement of a physician. |
| adult and pediatric patients. | | |
| Range | 0 ~ 100% | 0 ~ 100% |
| Accuracy | ±2% SpO2 (for 70 ~ 100%
Spo2)(1SD)
Unspecified for 069% SpO2 | ±2% SpO2 (for 70 ~ 100%69% SpO2 |
Spo2)(1SD)
Unspecified for 0
| Resolution | 1% | 1% |
| Audio | Pitch of pulse tone varies with
Spo2 value | Pitch of pulse tone varies with Spo2
value |
| Principle | Using the time between
successive pulses | Using the time between successive
pulses |
| Range | 30250bpm | 30250 bpm |
| Accuracy | ±1bpm or ±2% (take the larger
one) | ±1% of full scale |
| Resolution | 1bpm | 1bpm |
| Principle | On-airway using an infrared
absorption (IR) technique | On-airway using an infrared
absorption (IR) technique |
| Range | 0150 mmHg | 0 ~ 150 mmHg |40mmHg)
| Accuracy | ±2 mmHg (0
±5% of reading (4170mmHg)100mmHg)
±8% of reading (71
±10% (101150mmHg) | ±2 mmHg (040mmHg)
±5% of reading (4170mmHg)100mmHg) |
±8% of reading (71
| Resolution | 1 mmHg | 1 mmHg |
| Range | 2150bpm | 0150bpm |
| Accuracy | ±1bpm | ±1bpm |
5
6
| Newtech, Inc. | |
|---|---|
| K123797Additional Information - Exhibit#3 510(K) SUMMARY |
| External Power
| Supply Input | 100~240 VAC,50/60Hz | 100~250 VAC,50/60Hz |
|---|---|---|
| Battery | 4 AA alkaline batteries or Ni-mh batteries | Nickel-metal-hydride or Standard AA lithium |
Table E3-2 Comparison of the SpO2 Accuracy per Decade
| Item | | NT1D vital
signs monitor
with sensor
S400A | Tidal Wave SP
pulse oximeter / carbon
dioxide monitor
(Models 710/715) | NT1/NT1A Pulse
Oximeter with
sensor S400A
(cleared K073249) |
|-------------------|----------|-----------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------|
| SpO2
Accuracy | 70%-80% | $\pm$ 2% | Unspecified | Unspecified |
| | 80%-90% | $\pm$ 2% | Unspecified | Unspecified |
| | 90%-100% | $\pm$ 2% | Unspecified | Unspecified |
| | 70%-100% | $\pm$ 2% | $\pm$ 2% | $\pm$ 2% |
| Item | | NT1D vital
signs monitor
with sensor
S400P | TidalWave SP
pulse oximeter / carbon
dioxide monitor
(Models 710/715) | NT1/NT1A Pulse
Oximeter with
sensor S400P
(cleared K073249) |
| SpO2,
Accuracy | 70%-80% | $\pm$ 2% | Unspecified | Unspecified |
| | 80%-90% | $\pm$ 2% | Unspecified | Unspecified |
| | 90%-100% | $\pm$ 2% | Unspecified | Unspecified |
| | 70%-100% | $\pm$ 2% | $\pm$ 2% | $\pm$ 2% |
| Item | | NT1D vital
signs monitor
with sensor
T400A | Tidal Wave SP
pulse oximeter / carbon
dioxide monitor
(Models 710/715) | NT1/NT1A Pulse
Oximeter with
sensor S400A
(cleared K073249) |
| SpO2
Accuracy | 70%-80% | $\pm$ 2% | Unspecified | Unspecified |
| | 80%-90% | $\pm$ 2% | Unspecified | Unspecified |
| | 90%-100% | $\pm$ 2% | Unspecified | Unspecified |
| | 70%-100% | $\pm$ 2% | $\pm$ 2% | $\pm$ 2% |
Predicate devices TidalWave SP pulse oximeter / carbon dioxide monitor, and NTI/NT1A have no SpO2 Accuracy description in the discrete range of 70%-80%, 80%-90% and 90%-100%. But all the NTID SpO2 Accuracy per decade is ±2%, same as SpO2 Accuracy of 70%-100% of predicate devices. And NTID and NT1/NT1A Pulse Oximeter share two same sensors S400P and S400A. Therefore, NT1D and predicate devices are substantially equivalent.
7
Clinical trial conclusion 8.0
NTID vital signs monitor has two measurement modules, which are CO2 module and SpO2 module. The CO2 module has gotten 510(k) number. Capnostat 5 CO2 Sensor numbered K042601 and LoFlo C5 CO2 Sensor numbered K053174. SpO2 model includes three types of sensors, which are S400A, S400P, T400A. S400A and S400P are the finger sensors of the predicate device NT1/NT1A which numbered K073249. And clinical trial was conducted on NTID with T400A sensor. The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO9919:2005 Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for the medical use on ten healthy volunteers, in Hypoxia Research Laboratory, University of California, San Francisco.
It is notable that for the T400A-160108 sensor, over half (60%) of the individual subjects, the sensors performed with ARMS 3.0%, discussed in detail as requested) nevertheless meets the stated accuracy claims.
9.0 -Conclusion:
The conclusions drawn from nonclinical test and clinical tests of the NTID Vital Signs Monitor demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the TidalWave SP pulse oximeter / carbon dioxide monitor numbered K032971, NT1/NT1A Handheld Pulse Oximeter numbered K073249, Capnostat 5 CO2 Sensor numbered K042601 and LoFlo C5 CO2 numbered K053174.
10.0 Prepared Date: August 10, 2013
8
Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration
Silver Spring, MD 20993-0002
10903 New Hampshire Avenue Document Control Center - WO66-G609
August 27, 2013
New Tech, Incorporated C/O Ms. Diana Hong General Manager MID-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237
Re: K123797
Trade/Device Name: Vital Signs Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 24, 2013 Received: July 29, 2013
Dear Ms. Hong:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
9
Page 2 - Ms. Hong
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mary-S.Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Newtech, Inc.
Section ] 《Indications for use statement》
Indications for use statement
510(k) Number (if known): 123797
Device Name: Vital Signs Monitor Model: NTID
Indications For Use:
NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.
Prescription Use X_ (Part 21 CFR 801 Subpart D)
. ... . . . . .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Lester W. Schultheis Jr 2013.08.27 09:26:23 -04'00'
(Division Sign-Off) (Division Sign-On)
Division of Anasthesiology, General Hospital Division Control, Dental Devices
| -1 510(k) Number_123797