K231688
- 510(k) number
- K231688
- Device name
- ImPACT Version 4
- Applicant
- Impact Applications, Inc. IA · US
- Product code
- POM — Computerized Cognitive Assessment Aid For Concussion
- Decision date
- 2023-09-16
- Date received
- 2023-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231688.pdf
Official FDA record: K231688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.