De Novo DEN150037
- Device
- ImPACT Computerized Neurocognitive Concussion Management Aid
- Contact
- michael zagorski
- De Novo number
- DEN150037
- Product code
- POM
- Regulation
- 882.1471
- Classification name
- computerized cognitive assessment aid for concussion
- Decision
- granted (DENG)
- Decision date
- 2016-08-22
- Date received
- 2015-08-11
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- POM
- Device name
- Computerized Cognitive Assessment Aid For Concussion
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.1471
- Implant
- N
- Life sustain/support
- N