The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion.

Device Description

The pulse oximeter, Model OHT60 and OXH78, consists of probe, electronic circuits, and display and plastic enclosures, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a professional healthcare facility or home conditions when physician follow-up and operated by a physician. This medical device can be reused. Not for continuously monitoring.

SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The measurement principle of Pulse oximeter is based on the absorption spectrum characteristics of hemoglobin and oxyhemoglobin in red and infrared regions, and the empirical formula of data is established by using ' Lambert Beer ' law. The working principle of the instrument adopts photoelectric blood oxygen detection technology combined with volume pulse recording technology, The specific process is as follows: Firstly, the infrared light emitting at 660 nm and the near-infrared light emitting at 905 are used to irradiate the finger and the measurement data are obtained by the infrared receiver tube. Secondly, the obtained measurement data were calculated and processed by electronic circuits and microprocessors to obtain the blood oxygen saturation and pulse rate, and the calculation results were displayed on the screen.

The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA alkaline batteries.

The Model OHT60 and OXH78 have the same critical components and its materials and means of power supply, PCB layout and Software are little different.

AI/ML Overview

The provided text describes the 510(k) summary for a Pulse Oximeter (Models OHT60, OXH78). This document primarily details the device's technical specifications, non-clinical testing, and a clinical study to demonstrate its accuracy against a predicate device. It does not describe a study involving an AI component or a multi-reader multi-case (MRMC) comparative effectiveness study, as the device is a standalone hardware product (pulse oximeter).

Therefore, I will focus on the acceptance criteria and the study that proves the device meets those criteria based on the information available for this specific medical device.

Device Name: Pulse Oximeter (Model OHT60, OXH78)
Intended Use: Spot-checking oxygen saturation and pulse rate in adults, reusable device, for use with the finger in professional healthcare facilities or home conditions with physician follow-up. Not intended for use under motion.

Acceptance Criteria and Reported Device Performance

The primary performance criterion for this pulse oximeter is its accuracy in measuring SpO2. The relevant standard cited is ISO 80601-2-61:2017. This standard typically specifies the acceptable accuracy (Root Mean Square, ARMS) for pulse oximeters over a defined SpO2 range.

Table 1: Acceptance Criteria and Reported Device Performance (SpO2 Accuracy)

Criterion (from ISO 80601-2-61:2017 & FDA Guidance)	Acceptance Level	Reported Device Performance	Comments
SpO2 Accuracy (ARMS) for 70-100% SpO2 range	≤ 3.0 % (Typical)	1.98 %	Meets the generally accepted criterion for pulse oximeter accuracy within the specified range.

Note: While the predicate device had an SpO2 accuracy of ±2% and the subject device has ±3%, the document states "The SpO2 measurement range and accuracy is a little different, but they are within the limits of the specified range of the standard ISO 80601-2-61 and FDA guidance for Pulse Oximeters. The different has no effect on substantive equivalence." This implies that the ±3% for the subject device is within the acceptable range defined by the standard and FDA guidance.

Study Details to Prove Device Meets Acceptance Criteria

The study described is a clinical accuracy study for the pulse oximeter.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 12 healthy adult volunteer subjects.
- Data Provenance: Clinical study conducted at Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, China (implied from the submitter's country and study location). The study was prospective as it involved inducing fractional inspiration O2 (FiO2) control tests and obtaining arterial blood samples.
- Subject Demographics: Ages 21-42 years, 46-75 kg, 150-180 cm. Included 4 males and 8 females, with varying skin pigmentations (4 subjects with Fitzpatrick V, VI, and 8 subjects with Fitzpatrick I ~ Fitzpatrick IV).
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The ground truth for SpO2 (SaO2) was established by an arterial blood gas analyzer (CO-OXIMETER), which is a laboratory instrument. Experts were involved in conducting the clinical study, drawing arterial blood, and operating the analyzer, but the ground truth itself is an instrumental measurement, not expert consensus reading of images or similar. The document does not specify the number or specific qualifications of medical professionals involved in operating the CO-OXIMETER or conducting the clinical measurements beyond being part of the clinical study team at the hospital.
Adjudication Method for the Test Set:
- Not applicable as the ground truth (SaO2) was obtained directly from an arterial blood gas analyzer, not through human interpretation requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic imaging tool that would typically involve human readers.
If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the clinical study assessed the "standalone" performance of the pulse oximeter device itself by comparing its SpO2 readings directly against the functional oxygen saturation (SaO2) from the arterial blood gas analyzer. The device provides a direct measurement, not an output that requires further human interpretation for its primary function.
The Type of Ground Truth Used:
- Outcomes Data/Physiological Measurement: The ground truth used was functional oxygen saturation (SaO2) measured by an arterial blood gas analyzer (CO-OXIMETER) from stable arterial blood samples. This is considered a gold standard for blood oxygen measurement.
The Sample Size for the Training Set:
- The document does not specify a separate "training set" in the context of machine learning. The device is a hardware product relying on established physiological principles (spectrophotometry, photoplethysmography) and empirical formulas, not a "learnable" AI algorithm in the contemporary sense that would require a distinct training set for model development. The clinical study data (12 subjects) described is the test set used for validation of the device's accuracy.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as a distinct training set for an AI model is not described or relevant for this type of device. The underlying principles and empirical formulas are based on general scientific and medical knowledge, rather than specific data training.

Summary

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January 4, 2024

Cofoe Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai. Shanghai 200120 China

Re: K230277

Trade/Device Name: Pulse Oximeter(Model OHT60,OXH78) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 30, 2023 Received: December 4, 2023

Dear Boyle Wang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley O. Quinn -

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,

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Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230277

Device Name Pulse Oximeter (Model OHT60,OXH78)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K230277

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's Information

Name:	Cofoe Medical Technology Co., Ltd.
Address:	No. 87, Section 1 of Huanbao East Road, Yuhua District,410000 Changsha, Hunan, PEOPLE'S REPUBLIC OF CHINA
Tel:	86-18674772941
Contact:	Ms. Yang Cui
Registration Number:	3016426850

Designated Submission Correspondent

Contact:	Mr. Boyle Wang
Name:	Shanghai Truthful Information Technology Co., Ltd.
Address:	Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai200120 China
Tel:	+86-21-50313932
Email:	Info@truthful.com.cn

Date of Preparation: Dec.25,2023

2.0 Device Information

Trade name:	Pulse Oximeter
Common name:	Pulse Oximeter
Classification name:	Oximeter
Model(s):	Model OHT60, Model OXH78
Production code:	DQA
Regulation number:	21 CFR 870.2700
Classification:	Class II
Panel:	Anesthesiology

3.0 Predicate Device Information

Manufacturer:	Huizhou Xiaoou Technology Co., Ltd.
Trade name:	Pulse Oximeter (Model Number-SO611), Pulse Oximeter (ModelNumber-SO711), Pulse Oximeter (SO811), Pulse Oximeter

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	(SO911)
510(k) number:	K212665

4.0 Indication for Use Statement

5.0 Device Description

The Model OHT60 and OXH78 have the same critical components and its materials and means of power supply, PCB layout and Software are little different.

6.0 Technological Characteristics

Principle of Operation

The module utilizes the same principles of operation for pulse oximetry governed by the following principles:

Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood)

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differ in their absorption of red and infrared light (spectrophotometry).

The amount of arterial blood in tissue changes with your pulse 2. (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

Mechanism of Action for Achieving the Intended Effect

A mathematic formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoqlobin (Hbo2) in red and near-infrared zones. Operation principle of the instrument: Photoeletric Oxyhemoglobin Inspection Technology adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused on a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeters display through process in electronic circuits and microprocessor.

7.0 Non-clinical Testing Summary

The following performance data have been conducted to verify that the Oximeter meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:

Conclusions for Biocompatibility Testing

The biocompatibility evaluation for the oximeter was conducted in accordance with the FDA's Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" , as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of permanent (>30 days). And the testing included the following tests:

Cytotoxicity, per ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

Skin Sensitization and Skin Irritation, per ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

According to the Attachment G: Biocompatibility of Certain Devices in

Contact with Intact Skin of FDA Guidance Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued on: September 8, 2023. Acrylonitrile butadiene styrene (ABS), Polycarbonate (PC) and Silicone materials are considered to pose a very low biocompatibility risk because they have a long history of safe use in medical devices that contact intact skin.

So the specific biocompatibility testing for Case, Keys and Silicone are not necessary.

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Electrical and EMC Safety:

The electrical safety and EMC safety testing was performed to, and passed, the following standards:

IEC 60601-1:2005/AMD2:2020, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance

IEC 60601-1-11 Edition 2.0 2015-01, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances - Requirements and tests

Summary of Bench Testing

Bench testing was conducted and the results show that the subject device complies with the below standard:

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02), Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Software Verification and Validation Testing

Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.

The Software Validation is in compliance with FDA Guidance.

Summary of Shelf Life and Cleaning Testing

The service life has been verified through accelerated aging. The service life is 5 years except the battery is reasonable and effective.

Cleaning and disinfection validation testing was conducted in accordance with FDA quidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the User manual.

8.0 Clinical Test Summary

Clinical studies were conducted at Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University to verify the accuracy of the subject device.

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The clinical study was conducted in accordance to ISO80601-2-61:2017, ISO14155:2020, and the FDA Guidance Document for Pulse Oximeters. The subject device of this study was to verify the accuracy of pulse oximetry (SpO2) measured by the oximeter with a measurement range of 70-100% in the static state.

The induced Fraction of inspiration O2 (FiO2) control test was performed on subjects, and the subjects were subjected to radial artery puncture and indwelling catheter to obtain a stable arterial blood sample. The pulse oxygen saturation (SpO2) measured by the oximeter is compared with the functional oxygen saturation (SaO2) in arterial blood is analyzed by the arterial blood gas analyzer(CO-OXIMETER).

12 healthy adult volunteer subjects (ages 21-42yr, 46-75kg, 150-180cm, with light to dark pigmentation) were included in the study conducted to evaluate and complete the SpO2 accuracy performance of the Pulse Oximeter. 4 males and 8 females (including 4 subjects with Fitzpatrick V, VI, 8 subjects with Fitzpatrick I ~ Fitzpatrick IV).

SubjectNo	Site	EnrollmentDate	TreatmentReceived	Adherence toProtocol	AdverseEvents
1~12	Sir Run Run ShawHospital, 01 Schoolof Medicine,Zhejiang University	2021.07.26	OHT60 PulseOximeter	Yes	No

The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer.

The SpO2 accuracy performance results showed the subject Pulse Oximeter to have an ARMS of 1.98 during steady state conditions over the range of 70-100%.

9.0 Technological Characteristic Comparison Table

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Item	Subject DeviceK230277	Predicate DeviceK2126665	Remark
Product Name	Pulse Oximeter	Pulse Oximeter	--
Manufacturer	Cofoe Medical Technology Co., Ltd.	Huizhou Xiaoou Technology Co., Ltd.	--
Product Code	DQA	DQA	Same
Regulation No.	21CFR 870.2700	21CFR 870.2700	Same
Class	Class II	Class II	Same
Model	OHT60,OXH78	SO611,SO711,SO811,SO911	--
IntendedUse/Indication forUse	The Pulse Oximeter is intended for spot-checking oxygen saturation and pulserate, and the device is a reusable deviceand intended to be used with the fingerof adults in professional healthcarefacility or home conditions whenphysician follow-up and operated by aphysician. And it is not intended to beused under motion.	The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate,and the device is a reusable deviceand intended to be used with the finger ofadults in professional healthcare facility orhome conditions when physicianfollow-up and operated by a physician. Andit is not intended to be used under motionor low perfusion scenarios.	Same
Principle	The oximeter consists of probe,electronic circuits, and display andplastic enclosures. And one side ofprobe is designed to locate light emittingdiodes and a light detector (called aphoto-detector). Red and Infrared lightsare shone through the tissues from oneside of the probe to the other. Thenparts of the light emitted absorbed byblood and tissues. The light absorbed bythe blood varies with the oxygensaturation of haemoglobin. After that,the photo-detector detects the lightvolume transmitted through the tissueswhich depends on blood pulse,Hereafter, the microprocessor calculatesa value for the oxygen saturation(SpO2).	The oximeter consists of probe, electroniccircuits, and display and plastic enclosures.And one side of probe is designed to locatelight emitting diodes and a light detector(called a photo-detector). Red and Infraredlights are shone through the tissues fromone side of the probe to the other. Thenparts of the light emitted absorbed by bloodand tissues. The light absorbed by theblood varies with the oxygen saturation ofhaemoglobin. After that, the photo-detectordetects the light volume transmittedthrough the tissues which depends onblood pulse, Hereafter, the microprocessorcalculates a value for the oxygensaturation (SpO2).	Same
AppliedPopulation	Adults in home & hospital	Adults in home & hospital	Same
Application sites	Finger	Finger	Same
Display Type	LED	LED	Same
Display Content	OHT60: Display the SPO2, PR, pulseintensity histogram, Oxygen saturationvalue of pulse and battery power status.OXH78: Display the SPO2, PR, pulseintensity histogram, perfusionindex, pulse waveforms and battery powerstatus	Display the SpO2%, PR, battery indicator,Pulse rate bar graph, pulse waveform	Similar
Contactingmaterial	Shell: ABSClip pad: SiliconKey:PC	Not Publicly available	Different
Item	Subject DeviceK230277	Predicate DeviceK212665	Remark
Model	OHT60, OXH78	SO611,SO711,SO811,SO911	/
LED wavelength	Red= 660 nm; Infrared=905nm	Red= 660 nm; Infrared=905nm	Same
Power source	2*1.5V AAA alkaline battery	2*1.5V AAA alkaline battery	Same
Display	OHT60: SpO2%; PR; battery level; Pulseintensity histogram.OXH78: SpO2%; PR; battery level; Pulseintensity histogram, Pulse wave form	SpO2%; PR	Same
SpO2 MeasuringRange	35%-100%	0%-100%	Different
SpO2 Resolution	1%	1%	Same
SpO2 Accuracy	70~100%, ±3%;0% to 69%: unspecified	70~100%, ±2%;0% to 69%: unspecified	Similar
PR MeasuringRange	30-250BPM	30-250BPM	Same
PR Resolution	1 bpm	1 bpm	Same
PR Accuracy	± 3bpm	± 3bpm	Same

Table1-General Comparison

Analysis:

Materials of the predicate device is not publicly available. The

biocompatibility evaluation has performed and passed on the subject device and the predicate device per the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

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Table 2 Performance Comparison

Analysis:

The SpO2 measurement range and accuracy is a little different, but they are within the limits of the specified range of the standard ISO 80601-2-61 and FDA guidance for Pulse Oximeters. The different has no effect on substantive equivalence.

Table 3 Safety Comparison

Item	Subject DeviceK230277	Predicate DeviceK212665	Remark
Electrical Safety	Comply with IEC 60601-1IEC 60601-1-11	Comply with IEC 60601-1IEC 60601-1-11	Same
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Same
Performance	ISO 80601-2-61	ISO 80601-2-61	Same
Biocompatibility	Comply with ISO 10993-1,FDA Guidance	Comply with ISO 10993-1,FDA Guidance	Same

10.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.

Regulation Number and Section

§ 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).