510(k) K253607 ยท SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
UNEEG EpiSight System
| Applicant | Uneeg Medical A/S, Alleroed, DK |
| Decision | Substantially Equivalent, Jun 11, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253607
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.