K201376 is an FDA 510(k) clearance for the ANAM Test System. This device is classified as a Computerized Cognitive Assessment Aid For Concussion (Class II - Special Controls, product code POM).
Submitted by Vista Lifesciences, Inc. (Englewood, US). The FDA issued a Cleared decision on March 25, 2021, 303 days after receiving the submission on May 26, 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 | K201376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2020 |
| Decision Date | March 25, 2021 |
| Days to Decision | 303 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. |