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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
510(k) Number K262318
Device Name Minder® System
Applicant
Epi-Minder Pty, Ltd.
Office 210/211 W. Podium, Mezzanine 2
525 Collins St.
Melbourne,  AU 3000
Applicant Contact Tracy Cameron
Correspondent
Epi-Minder Pty, Ltd.
Office 210/211 W. Podium, Mezzanine 2
525 Collins St.
Melbourne,  AU 3000
Correspondent Contact Tracy Cameron
Classification Product Code
SEM  
Date Received07/08/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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