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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K243185
Device Name REMI Remote EEG Monitoring System
Applicant
Epitel
465 S 400 E.
Suite 250
Salt Lake City,  UT  84111
Applicant Contact Christopher Phillips
Correspondent
Epitel
465 S 400 E.
Suite 250
Salt Lake City,  UT  84111
Correspondent Contact Christopher Phillips
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GXY  
Date Received09/30/2024
Decision Date 03/21/2025
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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