QOK — Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate Class II
FDA product code QOK covers "Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate", a Class II medical device regulated under 21 CFR 870.2786. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QOK
- Device Class
- Class II
- Regulation Number
- 870.2786
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200038 | continuse biometrics | Gili Pro BioSensor (also known as Gili BioSensor System) | April 1, 2021 |