FDA Product Code
FDA Product Code POM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1471
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241737 | Sway System Sports Plus | Sway Medical, Inc. | 2025-02-15 | Traditional | PDF ↗ |
| K231688 | ImPACT Version 4 | Impact Applications, Inc. | 2023-09-16 | Traditional | PDF ↗ |
| K201376 | ANAM Test System | Vista Lifesciences, Inc. | 2021-03-25 | Traditional | PDF ↗ |
| K202485 | ImPACT Version 4 | Impact Applications, Inc. | 2020-12-25 | Traditional | PDF ↗ |
| K181223 | ImPACT | Impact Applications, Inc. | 2018-10-20 | Traditional | PDF ↗ |
| K170551 | ImPACT Quick Test | Impact Applications, Inc. | 2017-06-21 | Traditional | PDF ↗ |
| K170209 | ImPACT | Impact Applications, Inc. | 2017-02-23 | Special | PDF ↗ |
| DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Impact Applications, Inc. | 2016-08-22 | Direct | — |
Product code POM · Class II · Neurology. Data: openFDA.