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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 K240408
Device Name REMI-AI Rapid Detection Module (REMI-AI RDM)
Applicant
Epitel, Inc.
465 S 400 E.
Suite 250
Salt Lake City,  UT  84111
Applicant Contact Randy Parry
Correspondent
Epitel, Inc.
465 S 400 E.
Suite 250
Salt Lake City,  UT  84111
Correspondent Contact Christopher Phillips
Regulation Number882.1400
Classification Product Code
OMB  
Date Received02/09/2024
Decision Date 10/17/2024
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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