Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.2786
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.