Skip to contentDe Novo DEN200019
- Device
- Oxehealth Vital Signs
- Contact
- hugh lloyd-jukes
- De Novo number
- DEN200019
- Product code
- QME
- Regulation
- 870.2785
- Classification name
- software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
- Decision
- granted (DENG)
- Decision date
- 2021-03-26
- Date received
- 2020-03-27
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QME
- Device name
- Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.2785
- Implant
- N
- Life sustain/support
- N