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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 K253607
Device Name UNEEG EpiSight System
Applicant
Uneeg Medical A/S
Borupvang 2
Alleroed,  DK 3450
Applicant Contact Camilla Wismar
Correspondent
Uneeg Medical A/S
Borupvang 2
Alleroed,  DK 3450
Correspondent Contact Camilla Wismar
Classification Product Code
SEM  
Date Received11/18/2025
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT02402153
NCT02925676
NCT04513743
NCT04526418
NCT05111847
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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