UNEEG EpiSight System— 510(k) K253607
Substantially EquivalentUneeg Medical A/S
FDA 510(k) clearance K253607 for UNEEG EpiSight System, Substantially Equivalent on 2026-06-11. Applicant: Uneeg Medical A/S. Device class: 2.
Summary
Uneeg Medical's UNEEG EpiSight System is filed under SEM, sub-scalp implanted electroencephalogram systems for remote patient monitoring. The record doesn't list the system's components.
Class II, 21 CFR 882.1360. Neurology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Uneeg filed from Alleroed, Denmark. Review took 205 calendar days (November 18, 2025 to June 11, 2026).
Clearance details
- Applicant
- Uneeg Medical A/S
- Product code
- Product code SEM
- Device class
- Class 2
- Regulation
- 21 CFR 882.1360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alleroed, DK
Recent devices under product code SEM
view allData sourced from openFDA. This site is unofficial and independent of the FDA.