UNEEG EpiSight System
FDA 510(k) clearance K253607 · decided 2026-06-11
Clearance details
- K-number
- K253607
- Device name
- UNEEG EpiSight System
- Applicant
- Uneeg Medical A/S
- Decision
- Substantially Equivalent
- Date received
- 2025-11-18
- Decision date
- 2026-06-11
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- SEM
- Device class
- 2
- Regulation number
- 882.1360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alleroed, DK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Minder System (DEN240062) | Epi-Minder Pty, Ltd. | 2025-04-17 |
Recalls involving this device
No recalls on record reference this clearance.