510(k) K253607
K253607 is an FDA 510(k) premarket notification submitted by Uneeg Medical A/S for the device "UNEEG EpiSight System". The FDA issued a decision of Substantially Equivalent on Jun 11, 2026. The device falls under product code SEM (Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring), a Class II device regulated under 21 CFR 882.1360.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 11, 2026
- Date Received
- Nov 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
- Device Class
- Class II
- Regulation Number
- 882.1360
- Review Panel
- NE
- Submission Type
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.