(29 days)
Not Found
No
The device description focuses on hardware components (LEDs, photodetector, resistor) and traditional signal processing for SpO2 and pulse rate measurement. There is no mention of AI, ML, or related concepts in the document.
No
The device is described as a sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring, which are diagnostic/monitoring functions, not therapeutic.
Yes
Explanation: The device is intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring, which are diagnostic measurements used to assess a patient's physiological state.
No
The device description explicitly states that the device is a "Disposable Sensor" containing physical components like LEDs, a photodetector, and a resistor. It also requires connection to other hardware (standalone oximeters or modular patient monitors) via interconnect cables. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring." This involves measuring physiological parameters directly from the patient's body.
- Device Description: The description details how the sensor uses light and a photodetector to measure these parameters through tissue. This is a non-invasive method.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVDs are specifically designed for testing such specimens.
Therefore, the device described is a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
TS-AAW-10 and TS-AAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds)
TS-PAW-10 and TS-PAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds)
Product codes (comma separated list FDA assigned to the subject device)
DOA
Device Description
The TruSignal SpO2 Adult and Pediatric Disposable Sensors are used together with standalone oximeters or modular patient monitors to measure continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
The sensors are to be connected to a device using an interconnect cable TS-G3, TS-M3, TS-H3 or TS-N3 (cleared in K093881). The interconnect cable type depends on the monitor end connector of the device.
The sensors contain light emitting diodes (LEDs) that emit light of different wavelengths. The sensors also contain a photodetector for detecting the emitted light after it has been attenuated by tissue. The sensors further contain a resistor, which is used to encode the wavelength of the LEDs used in the sensor. The resistor value is read by the monitor to determine the calibration curve used for that specific sensor.
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: > 20 kg (>44 pounds)
Pediatric: 3-20 kg (6.6-44 pounds)
Intended User / Care Setting
Not Found
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
Summary of Clinical Tests:
Clinical verification tests were performed on the proposed devices on an extensive selection of GE patient monitors.
TruSignal SpO2 Adult Disposable Sensor: The test consisted of induced hypoxia studies on healthy adult volunteers (ages 19-31 yr.) conducted in an independent research laboratory. The measured arterial hemoglobin saturation values of the proposed devices were compared to CO-oximeter based arterial hemoglobin saturation values.
TruSignal SpO2 Pediatric Disposable Sensor did not require clinical studies to support substantial equivalence.
TruSignal SpO2 Pediatric Disposable Sensor has identical materials and electro-optical components and equivalent sensor characteristics to TruSignal SpO2 Adult Disposable Sensor, thus the clinical data from Adult Disposable Sensor applies to this sensor as well.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical verification tests, induced hypoxia studies.
Sample Size: Healthy adult volunteers (ages 19-31 yr.)
Key Results: The proposed sensor was shown to have an A_RMS of less than 2 during steady state conditions over the range of 70-100%. The S5 Compact Monitors with an E-PRESTN module meets an A_RMS of less than 2.5% for the same range. The results of the study provide supporting evidence that the SpO2 accuracy performance of the new design of the GE Healthcare disposable sensors does not adversely affect the SpO2 accuracy performance and the proposed sensors pass the respective A_RMS specifications under steady state / non-motion conditions for the range 70-100% as stated in the Instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (A_RMS)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TruSignal SpO2 Allfit Sensor cleared in K093881 TruSignal® Sensors and Interconnect Cables
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K132 bab
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "g" and "e" intertwined within a circular border. The logo is in black and white.
GE Healthcare Finland Oy
Kuortaneenkatu 2, P.O. Box 900 ビ
Finland
T: +358 10 39411
T: +358 10 39411
F: +358 10 39411
F: +358 9 1463310
510(k) Summary
In accordonce with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 27, 2013 | |
|---|---|---|
| Owner/Submitter: | GE Healthcare Finland Oy | |
| Kuortaneenkatu 2 | ||
| FIN-00510 Helsinki, Finland | ||
| Primary Contact Person: | Joel Kent | |
| Manager, Quality and Regulatory Affairs | ||
| GE Healthcare | ||
| Phone: 781-449-8685 | ||
| Fax: 781-433-1344 | ||
| E-mail: joel.kent@ge.com | ||
| Secondary Contact Person: | Rauno Ruoho | |
| Regulatory Affairs Manager | ||
| GE Healthcare Finland Oy | ||
| Kuortaneenkatu 2 | ||
| 00510 Helsinki | ||
| Finland | ||
| Phone: + 358 10 394 3624 | ||
| Fax: +358-92726532 | ||
| E-mail: Rauno.ruoho@ge.com | ||
| Device names (807.92(a)(2)): | Device Trade Name: | |
| TruSignal® SpO2 Adult and Pediatric Adhesive Wrap Disposable | ||
| Sensors | ||
| Common/Usual Name: | ||
| Pulse Oximeter Sensors | ||
| Classification Names: | ||
| 21 CFR 870.2700 Oximeter | ||
| Product Code: | DOA | |
| Predicate Device(s) | ||
| (807.92(a)(3)): | TruSignal SpO2 Allfit Sensor cleared in K093881 TruSignal® Sensors | |
| and Interconnect Cables | ||
| Device Description | ||
| (807.92(a)(4)): | The TruSignal SpO2 Adult and Pediatric Disposable Sensors are used | |
| together with standalone oximeters or modular patient monitors to | ||
| measure continuous non-invasive arterial oxygen saturation (SpO2) | ||
| and pulse rate monitoring. | ||
| The sensors are to be connected to a device using an interconnect | ||
| cable TS-G3, TS-M3, TS-H3 or TS-N3 (cleared in K093881). The | ||
| interconnect cable type depends on the monitor end connector of | ||
| the device. | ||
| The sensors contain light emitting diodes (LEDs) that emit light of | ||
| different wavelengths. The sensors also contain a photodetector for | ||
| detecting the emitted light after it has been attenuated by tissue. The | ||
| sensors further contain a resistor, which is used to encode the | ||
| wavelength of the LEDs used in the sensor. The resistor value is read | ||
| by the monitor to determine the calibration curve used for that | ||
| specific sensor. | ||
| Intended Use (807.92(a)(5): | TS-AAW-10 and TS-AAW-25 | |
| The Disposable Sensor is a single-patient use sensor intended for | ||
| continuous non-invasive arterial oxygen saturation (SpO2) and pulse | ||
| rate monitoring. Patient weight range: > 20 kg (>44 pounds) | ||
| TS-PAW-10 and TS-PAW-25 | ||
| The Disposable Sensor is a single-patient use sensor intended for | ||
| continuous non-invasive arterial oxygen saturation (SpO2) and pulse | ||
| rate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds) | ||
| Technology | ||
| (807.92(a)(6)): | The TruSignal SpO2 Adult and Pediatric Disposable Sensors employ | |
| the same fundamental scientific technology as their predicate device | ||
| TruSignal SpO2 Allfit Sensor K093881. | ||
| The following is an overview of the differences between the proposed | ||
| TruSignal SpO2 Adult and Pediatric Disposable Sensors and the | ||
| predicate device: | ||
| Patient Population Equivalent to the predicate device: Patient weight range has been changed from all patients of the predicate device to 3-20 kg (6.6-44 pounds) of the TS-PAW proposed device and > 20 kg (>44 pounds) of the TS-AAW proposed device. Applicable Electromagnetic Compatibility, Electrical safety, Usability, biocompatibility, engineering verification tests (such as cleaning, and material durability) and clinical performance testing test report show that the proposed device is as safe and effective as the predicate K093881. | ||
| Anatomical Sites | ||
| Equivalent to the predicate device: | ||
| Palm of the hand and side of the foot excluded from | ||
| 0 | ||
| the application sites. | ||
| Applicable Electromagnetic Compatibility, Electrical | ||
| 0 | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881 | ||
| Environment of Use | ||
| Step down units added to the list of environments of | ||
| o | ||
| use of the proposed device. ESU removed from the list | ||
| of environments of use of the proposed device. | ||
| Applicable Electromagnetic Compatibility, Electrical | ||
| O | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Sensor head | ||
| Geometry and dimensions | ||
| 0 | ||
| TS-AAW-10 and TS-AAW-25: Identical to the predicate | ||
| 0 | ||
| device. | ||
| TS-PAW-10, TS-PAW-25: Equivalent to the predicate | ||
| O | ||
| device: Geometry is identical to the predicate device. | ||
| The distance of the optical components have been | ||
| changed to be slightly less compared to the predicate | ||
| device to better fit the finger of the smaller pediatric | ||
| patients. | ||
| Applicable Electromagnetic Compatibility, Electrical | ||
| O | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Equivalent to the predicate device in terms of | ||
| Materials | ||
| intended use. | ||
| Applicable Electromagnetic Compatibility, Electrical | ||
| o | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Electro-optical components Equivalent to the predicate | ||
| device: | ||
| • | ||
| • Identical LEDs, detector and leadframes. The color of | ||
| the sensor head have been changed from light pink | ||
| of the predicate device to white of the proposed | ||
| device. | ||
| • Applicable Electromagnetic Compatibility, Electrical | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Performance Equivalent to the predicate device: | ||
| • Accuracy of the TruTrak®, TruTrak+® technologies | ||
| changed to A_rms ± 2.5 digits in the range of 70% to | ||
| 100% SpO2 compared to ± 2 digits in the range of | ||
| 70% to 100% SpO2 of the predicate device. | ||
| • Accuracy of the Datex Ohmeda technology changed | ||
| to A_rms ± 2.5 digits in the range of 70% to 100% | ||
| SpO2 compared to ± 3 digits in the range of 70% to | ||
| 100% SpO2 of the predicate device. | ||
| • Applicable Electromagnetic Compatibility, Electrical | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881 | ||
| Biocompatibility: Identical to the predicate device. | ||
| • | ||
| • No change in the Body Contact materials | ||
| Connector Geometry and dimensions Equivalent to the | ||
| predicate device: | ||
| • The mating part of the connector is identical to the | ||
| predicate device. The size of the connector body of | ||
| the proposed devices is made smaller to reduce the | ||
| amount of material needed. | ||
| • Applicable Electromagnetic Compatibility, Electrical | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Materials (non body contact) Equivalent to the predicate | ||
| device: | ||
| Connector body materials have been changed | ||
| O | ||
| compared to the predicate device. Conductor | ||
| insulation and outer jacket materials have been | ||
| changed compared to the predicate device. Raw | ||
| cable tissue paper was removed from the raw cable | ||
| of the proposed device. | ||
| Applicable Electromagnetic Compatibility, Electrical | ||
| o | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Cable lengths Equivalent to the predicate device: | ||
| Applicable Electromagnetic Compatibility, Electrical | ||
| o | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Compatibility with other devices Equivalent to the predicate | ||
| device: | ||
| Removed discontinued platforms from the | ||
| 0 | ||
| compatibility list of the proposed devices and added | ||
| platforms released after the clearance of the | ||
| predicate device. | ||
| Applicable Electromoqnetic Compatibility, Electrical | ||
| 0 | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material - | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Electrical Safety Identical to the predicate device K093881. | ||
| Thermal Safety Identical to the predicate device K093881. | ||
| This comparison of the specifications demonstrates the functional | ||
| equivalence of the products. The differences discussed do not raise | ||
| new issues of safety and effectiveness. Verification and Validation | ||
| testing demonstrated that no adverse effects have been introduced | ||
| by these differences. | ||
| GE Healthcare believes that the TruSignal SpO2 Adult and Pediatric | ||
| Disposable Sensors are as safe and effective, and perform in a | ||
| substantially equivalent manner to the predicate TruSignal® SpO2 | ||
| Allfit sensor (K093881). | ||
| Determination of Substantial | ||
| Equivalence (807.92(b)(1)): | Summary of Non-Clinical Tests: | |
| The TruSignal SpO2 Adult and Pediatric Disposable Sensors and its | ||
| applications comply with voluntary standards. The following quality | ||
| assurance measures were applied to the development of the system | ||
| Risk Analysis | ||
| Requirements Reviews | ||
| Design Reviews | ||
| Testing on unit level (Module verification) | ||
| Integration testing (System verification) | ||
| Performance testing (Verification) | ||
| Safety testing (Verification) | ||
| Simulated use testing (Validation) | ||
| The TruSignal SpO2 Adult and Pediatric Disposable was designed and | ||
| tested for compliance to the following standards: | ||
| 1. IEC 60601-1 2005; Medical Electrical Equipment - Part 1: General | ||
| Requirements for Safety | ||
| 2. IEC 60601-1-2; Ed3. 2007; Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety and essential performance - | ||
| Collateral standard: Electromagnetic compatibility - Requirements | ||
| and tests | ||
| 3. ISO 9919 2009; Medical electrical equipment - Particular | ||
| requirements for the basic safety and essential performance of pulse | ||
| oximeter equipment for medical use | ||
| 4. ISO 10993-1:2009; Biological evaluation of medical devices | ||
| 5. IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: | ||
| General requirements for basic safety and essential performance - | ||
| Collateral standard: Usability - Edition 3.0 | ||
| 6. IEC 62366:2007 Medical devices - Application of usability | ||
| engineering to medical devices – Edition 1.0 | ||
| Clinical | ||
| (807.92(b)(2)): | Summary of Clinical Tests: | |
| Clinical verification tests were performed on the proposed devices on | ||
| an extensive selection of GE patient monitors. | ||
| TruSignal SpO2 Adult Disposable Sensor: The test consisted of | ||
| induced hypoxia studies on healthy adult volunteers (ages 19-31 yr.) | ||
| conducted in an independent research laboratory. The measured | ||
| arterial hemoglobin saturation values of the proposed devices were | ||
| compared to CO-oximeter based arterial hemoglobin saturation | ||
| values. |
The proposed sensor was shown to have an A_RMS of less than 2
during steady state conditions over the range of 70-100%. The S5
Compact Monitors with an E-PRESTN module meets an A_RMS of less
than 2.5% for the same range. The results of the study provide
supporting evidence that the SpO2 accuracy performance of the new
design of the GE Healthcare disposable sensors does not adversely
affect the SpO2 accuracy performance and the proposed sensors
pass the respective A_RMS specifications under steady state / non-
motion conditions for the range 70-100% as stated in the
Instructions for use.
TruSignal SpO2 Pediatric Disposable Sensor did not require clinical
studies to support substantial equivalence.
TruSignal SpO2 Pediatric Disposable Sensor has identical materials |
| | | and electro-optical components and equivalent sensor
characteristics to TruSignal SpO2 Adult Disposable Sensor, thus the
clinical data from Adult Disposable Sensor applies to this sensor as
well. |
| Conclusion | (807.92(b)(3)): | GE Healthcare considers the TruSignal SpO2 Adult and Pediatric
Disposable Sensors to be as safe, as effective, and performance is
substantially equivalent to the predicate device TruSignal SpO2 Allfit
Sensor (K093881). |
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Image /page/7/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2013
GE Healthcare Mr. Joel Kent Manager, Quality and Regulatory Affairs Kuortaneenkatu 2 FIN-00510 Helsinki, Finland
Re: K132696
Trade/Device Name: TruSignal SpO2 Adult and Pediatric Disposable Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 28, 2013 Received: August 29, 2013
Dear Mr. Kent:
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.
8
Page 2 - Mr. Kent
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2)CFR 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.
Image /page/8/Picture/7 description: The image shows a signature and some text. The text includes the phrase "Sincerely yours," and the name "Tejashri Purohit-Sheth, M.D." The text also includes the title "Clinical Deputy Director" and the acronym "DAGRID." The word "FOR" is at the bottom right.
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
9
Ki32696
Device Nome: TruSignal® SpO2 Adult and Pediatric Disposable Sensors
Indications for Use:
TS-AAW-10 and TS-AAW-25
510fk) Number (if known):
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds)
TS-PAW-10 and TS-PAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight ronge: 3-20 kg (6.6-44 pounds)
AND/OR Prescription Use_X lPart 21 CFR 801 Sub part DI
Over-The-Counter Use lPort 21 CFR 801 Subport Cl
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) - -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nayan J. Patel - S
2013.09.26 17:47:51 -04'00'
Division Sign-Off) ·vision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number K132696
28