K202485 is an FDA 510(k) clearance for the ImPACT Version 4. This device is classified as a Computerized Cognitive Assessment Aid For Concussion (Class II - Special Controls, product code POM).
Submitted by Impact Applications, Inc. (Coralville, US). The FDA issued a Cleared decision on December 25, 2020, 116 days after receiving the submission on August 31, 2020.
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 | K202485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2020 |
| Decision Date | December 25, 2020 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |