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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K191868
Device Name iCEWav Neuromonitoring Platform
Applicant
iCE Neurosystems, Inc.
1875 Connecticut Ave NW, Suite 12117
Washington,  DC  20007
Applicant Contact Allen Waziri
Correspondent
EAS Consulting Group, LLC
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Allison Komiyama
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLT  
Date Received07/12/2019
Decision Date 03/31/2020
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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