Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Regulation 882.1360
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SEM
| Company | 510(k)s | Recalls |
|---|---|---|
| Epi-Minder Pty, Ltd. | 1 | 0 |
| Uneeg Medical A/S | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2026 | K253607 | UNEEG EpiSight System Uneeg Medical A/S, DK | SEM |
| Apr 17, 2025 | DEN240062 | Minder System Epi-Minder Pty, Ltd., AU | SEM |
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