QOK

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

Product code: QOK
Device name: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
Device class: Class 2
21 CFR: 21 CFR 870.2786
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QOK

Classification and pathway per current FDA publications. Data from openFDA (CC0).