510(k) DEN240062
DEN240062 is an FDA 510(k) premarket notification submitted by Epi-Minder Pty, Ltd. for the device "Minder System". The FDA issued a decision of De Novo Granted on Apr 17, 2025. 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
- DENG (De Novo Granted)
- Decision Date
- Apr 17, 2025
- Date Received
- Oct 18, 2024
- Clearance Type
- Direct
- 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.