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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
510(k) Number K183241
FOIA Releasable 510(k) K183241
Device Name BrainScope TBI (Model: Ahead 400)
Applicant
Brainscope Company, Inc.
4350 E. W. Hwy., Suite 1050
Bethesda,  MD  20814
Applicant Contact Michael E Singer
Correspondent
Brainscope Company, Inc.
4350 E. W. Hwy., Suite 1050
Bethesda,  MD  20814
Correspondent Contact Michael E Singer
Regulation Number882.1450
Classification Product Code
PIW  
Subsequent Product Codes
OLU   PKQ  
Date Received11/21/2018
Decision Date 02/19/2019
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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