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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 K161068
Device Name Ahead 300
Applicant
BRAINSCOPE COMPANY INC
4350 East West Highway
Suite 1050
Bethesda,  MD  20814
Applicant Contact Michael Singer
Correspondent
BRAINSCOPE COMPANY INC
4350 East West Highway
Suite 1050
Bethesda,  MD  20814
Correspondent Contact Michael Singer
Regulation Number882.1450
Classification Product Code
PIW  
Subsequent Product Codes
OLU   PKQ  
Date Received04/15/2016
Decision Date 09/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02367300
Reviewed by Third Party No
Combination Product No
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