DEN150037 is an FDA 510(k) submission for the ImPACT Computerized Neurocognitive Concussion Management Aid. This device is classified as a Computerized Cognitive Assessment Aid For Concussion (Class II - Special Controls, product code POM).
Submitted by Impact Applications, Inc. (Pittsburgh, US). The FDA issued a Not Cleared (DENG) decision on August 22, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1471. For Use As An Assessment Aid In The Management Of Concussion..
| 510(k) Number | DEN150037 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 11, 2015 |
| Decision Date | August 22, 2016 |
| Days to Decision | 377 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | POM - Computerized Cognitive Assessment Aid For Concussion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1471 |
| Definition | For Use As An Assessment Aid In The Management Of Concussion. |