K253607
- 510(k) number
- K253607
- Device name
- UNEEG EpiSight System
- Applicant
- Uneeg Medical A/S DK
- Product code
- SEM — Sub-Scalp Implanted Electroencephalogram System For
- Decision date
- 2026-06-11
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253607.pdf
Official FDA record: K253607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.