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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
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