De Novo DEN130033
- Device
- COGNIVUE
- Contact
- charles j duffy
- De Novo number
- DEN130033
- Product code
- PKQ
- Regulation
- 882.1470
- Classification name
- computerized cognitive assessment aid
- Decision
- granted (DENG)
- Decision date
- 2015-06-05
- Date received
- 2013-06-12
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- PKQ
- Device name
- Computerized Cognitive Assessment Aid
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.1470
- Implant
- N
- Life sustain/support
- N