Product Code: QOK FDA class 2 21 CFR 870.2786

Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

Cardiovascular

The Hardware and Software for Optical Camera-Based Measurement of Heart Rate and Respiratory Rate is a cardiovascular device that uses an optical sensor system and software algorithms to analyze video signals and estimate pulse rate, heart rate, respiratory rate, and/or breathing rates, and is not intended to independently direct therapy. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.2786 in the Cardiovascular specialty. It carries product code QOK and is not an implant and not life-sustaining.

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Basic Information

Product Code: QOK
Device Class: FDA class 2
Regulation Number: 870.2786
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

Definition

The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.