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Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

FDA product code QME · 12 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2785
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-07-20 – 2026-06-18

The device uses software algorithms to 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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