The following data is part of a De Novo classification by Impact Applications, Inc. with the FDA for Impact Computerized Neurocognitive Concussion Management Aid.
| DeNovo ID | DEN150037 |
| Device Name: | ImPACT Computerized Neurocognitive Concussion Management Aid |
| Classification | Computerized Cognitive Assessment Aid For Concussion |
| Applicant | IMPACT APPLICATIONS, INC. 2000 Technology Drive, Suite 150 Pittsburgh, PA 15219 |
| Contact | Michael Zagorski |
| Product Code | POM |
| CFR Regulation Number | 882.1471 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2015-08-11 |
| Decision Date | 2016-08-22 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864127000318 | DEN150037 | 000 |
| 00864127000301 | DEN150037 | 000 |