QOK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2786
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Gili Pro BioSensor (also known as “Gili BioSensor System”) (DEN200038) | Continuse Biometrics , Ltd. | 2021-04-01 |
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Every clearance here is in the API, with alerts when new ones post.