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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hardware and software for optical camera-based measurement of heart rate and respiratory rate
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.
Product CodeQOK
Regulation Number 870.2786
Device Class 2

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