Product code QOK
- Device name
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN200038 | Gili Pro BioSensor (also known as “Gili BioSensor System”) | Continuse Biometrics , Ltd. | 2021-04-01 |