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ImPACT Computerized Neurocognitive Concussion Management Aid
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
510(k) DEN150037
Identifiers
- 510(k) Number
- DEN150037 FDA 510(k)
- FDA Product Code
- POM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1471 FDA 510(k)
- Regulation Number
- 882.1471 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
ImPACT Computerized Neurocognitive Concussion Management Aid by ImPACT Applications, Inc. — Class II — MDR, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN150037 | Class II | Active |
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Manufacturer
- Manufacturer
- ImPACT Applications, Inc.
Sources (2)
- FDA 510(k) DEN150037 24 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 19, 2026