K241737
- 510(k) number
- K241737
- Device name
- Sway System Sports Plus
- Applicant
- Sway Medical, Inc. OK · US
- Product code
- POM — Computerized Cognitive Assessment Aid For Concussion
- Decision date
- 2025-02-15
- Date received
- 2024-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241737.pdf
Official FDA record: K241737
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.