510(k) DEN150037
DEN150037 is an FDA 510(k) premarket notification submitted by Impact Applications, Inc. for the device "ImPACT Computerized Neurocognitive Concussion Management Aid". The FDA issued a decision of De Novo Granted on August 22, 2016. The device falls under product code POM (Computerized Cognitive Assessment Aid For Concussion), a Class II device regulated under 21 CFR 882.1471. Impact Applications, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 22, 2016
- Date Received
- August 11, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Cognitive Assessment Aid For Concussion
- Device Class
- Class II
- Regulation Number
- 882.1471
- Review Panel
- NE
- Submission Type
For use as an assessment aid in the management of concussion.