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

FDA product code QOK · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2786
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-09-22 – 2026-09-22

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.

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