De Novo DEN240062

Device: Minder System
Contact: tracy cameron
De Novo number: DEN240062
Product code: SEM
Regulation: 882.1360
Classification name: sub-scalp implanted electroencephalogram system for remote patient monitoring
Decision: granted (DENG)
Decision date: 2025-04-17
Date received: 2024-10-18
Classification advisory: Neurology
Review advisory: Neurology
Type: Direct

Current FDA Classification#

Product code: SEM
Device name: Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Medical specialty: Neurology
Device class: 2
Regulation: 882.1360
Implant: Y
Life sustain/support: N