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510(k) DEN240062

Minder System by Epi-Minder Pty, Ltd. — Product Code SEM

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 17, 2025
Date Received
October 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 patient’s brain. The device is not intended to be implanted in brain tissue.