FDA Product Code
FDA Product Code SEM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1360
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253607 | UNEEG EpiSight System | Uneeg Medical A/S | 2026-06-11 | Traditional | PDF ↗ |
| DEN240062 | Minder System | Epi-Minder Pty, Ltd. | 2025-04-17 | Direct | — |
Product code SEM · Class II · Neurology. Data: openFDA.