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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K231779
Device Name REMI AI Discrete Detection Module
Applicant
Epitel, Inc.
465 S 400 E
Suite 250
Salt Lake City,  UT  84111
Applicant Contact Christopher Phillips
Correspondent
Epitel, Inc.
465 S 400 E
Suite 250
Salt Lake City,  UT  84111
Correspondent Contact Randy Parry
Regulation Number882.1400
Classification Product Code
OMB  
Date Received06/16/2023
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03583957
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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