The following data is part of a premarket notification filed by Impact Applications, Inc. with the FDA for Impact Version 4.
| Device ID | K202485 |
| 510k Number | K202485 |
| Device Name: | ImPACT Version 4 |
| Classification | Computerized Cognitive Assessment Aid For Concussion |
| Applicant | ImPACT Applications, Inc. 2140 Norcor Ave., Suite 115 Coralville, IA 52241 |
| Contact | Michael Zagorski |
| Correspondent | Michael Zagorski ImPACT Applications, Inc. 2140 Norcor Ave., Suite 115 Coralville, IA 52241 |
| Product Code | POM |
| CFR Regulation Number | 882.1471 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2020-12-25 |