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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 K203827
Device Name REMI
Applicant
Epitel, Inc.
124 S. 400 E.
Salt Lake City,  UT  84111
Applicant Contact Mark Lehmkuhle
Correspondent
leanRAQA
12602 N Summer Wind Dr.
Marana,  AZ  85658
Correspondent Contact John Pappan
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GXY  
Date Received12/29/2020
Decision Date 03/29/2021
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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