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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name sub-scalp implanted electroencephalogram system for remote patient monitoring
De Novo Number DEN240062
Device Name Minder System
Requester
epi-minder pty, ltd.
384-388 albert st.
melbourne,  AU 3002
Contact tracy cameron
Regulation Number882.1360
Classification Product Code
SEM  
Date Received10/18/2024
Decision Date 04/17/2025
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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