SEM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1360
- Medical specialty
- Neurology
- Flags
- Implant
- FDA definition
- A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patients brain. The device is not intended to be implanted in brain tissue.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UNEEG EpiSight System (K253607) | Uneeg Medical A/S | 2026-06-11 |
| Minder System (DEN240062) | Epi-Minder Pty, Ltd. | 2025-04-17 |
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Every clearance here is in the API, with alerts when new ones post.