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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 K190815
FOIA Releasable 510(k) K190815
Device Name BrainScope TBI
Applicant
BrainScope Company, Inc.
4330 East West Highway, Suite #1000
Bethesda,  MD  20814
Applicant Contact Michael Singer
Correspondent
BrainScope Company, Inc.
4330 East West Highway, Suite #1000
Bethesda,  MD  20814
Correspondent Contact Michael Singer
Regulation Number882.1450
Classification Product Code
PIW  
Subsequent Product Codes
OLU   PKQ  
Date Received03/29/2019
Decision Date 09/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02477943
NCT02661633
NCT02957461
NCT03671083
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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