De Novo DEN160020
- Device
- CipherOx CRI Tablet
- Contact
- gordon van dusen
- De Novo number
- DEN160020
- Product code
- PPW
- Regulation
- 870.2200
- Classification name
- adjunctive cardiovascular status indicator
- Decision
- granted (DENG)
- Decision date
- 2016-12-21
- Date received
- 2016-05-24
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- PPW
- Device name
- Adjunctive Cardiovascular Status Indicator
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.2200
- Implant
- N
- Life sustain/support
- N