Skip to contentDe Novo DEN200038
- Device
- Gili Pro BioSensor (also known as “Gili BioSensor System”)
- Contact
- sagi polani
- De Novo number
- DEN200038
- Product code
- QOK
- Regulation
- 870.2786
- Classification name
- hardware and software for optical camera-based measurement of heart rate and respiratory rate
- Decision
- granted (DENG)
- Decision date
- 2021-04-01
- Date received
- 2020-06-12
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- 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
- 870.2786
- Implant
- N
- Life sustain/support
- N