K181223 is an FDA 510(k) clearance for the ImPACT. This device is classified as a Computerized Cognitive Assessment Aid For Concussion (Class II - Special Controls, product code POM).
Submitted by Impact Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on October 20, 2018, 165 days after receiving the submission on May 8, 2018.
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 | K181223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2018 |
| Decision Date | October 20, 2018 |
| Days to Decision | 165 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. |