510(k) K253607
- Device
- UNEEG EpiSight System
- Applicant
- Uneeg Medical A/S
- 510(k) number
- K253607
- Product code
- SEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-11
- Date received
- 2025-11-18
- Regulation
- 882.1360
- Classification name
- Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Camilla Wismar
- Address
- Borupvang 2 Alleroed DK 3450 3450
FDA Registration Numbers#
- 3039411139
- 3009092818
- 3039640505
- 3002806740
Source Documents#
Other 510(k) Records For Product Code SEM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN240062 | Minder System | Epi-Minder Pty, Ltd. | 2025-04-17 |