QOK · Class II · 21 CFR 870.2786

FDA Product Code QOK: Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate

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.

Leading manufacturers include Continuse Biometrics , Ltd..

1
Total
0
Cleared
293d
Avg days
2021
Since

FDA 510(k) Cleared Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate Devices (Product Code QOK)

1 devices
1–1 of 1

About Product Code QOK - Regulatory Context

QOK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →