Skip to contentDe Novo DEN150004
- Device
- EPIC ClearView System
- Contact
- nancy rizzo
- De Novo number
- DEN150004
- Product code
- PNA
- Regulation
- 882.1561
- Classification name
- evoked photon image capture device
- Decision
- granted (DENG)
- Decision date
- 2016-07-15
- Date received
- 2015-01-13
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- PNA
- Device name
- Evoked Photon Image Capture Device
- Medical specialty
- Neurology
- Device class
- 1
- Regulation
- 882.1561
- Implant
- N
- Life sustain/support
- N