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.
Clearance details
- Applicant
- Uneeg Medical A/S
- Product code
- 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
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