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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 K143643
Device Name Brainscope Ahead 200
Applicant
BRAINSCOPE COMPANY, INC.
4350 EAST-WEST HIGHWAY
SUITE 1050
bethesda,  MD  20814
Applicant Contact michael e singer
Correspondent
BRAINSCOPE COMPANY, INC.
4350 EAST-WEST HIGHWAY
SUITE 1050
bethesda,  MD  20814
Correspondent Contact michael e singer
Regulation Number882.1450
Classification Product Code
PIW  
Date Received12/22/2014
Decision Date 05/15/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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