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U.S. Department of Health and Human Services

Device Classification under Section 513(f)(2)(de novo)

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Device Classification Name brain injury adjunctive interpretive electroencephalograph assessment aid
De Novo Number DEN140025
Device Name BrainScope Ahead 100
Requester
BRAINSCOPE COMPANY, INC
4350 east-west hwy
suite 1050
bethesda,  MD  20814
Contact michael e. singer
Regulation Number882.1450
Classification Product Code
PIW  
Date Received08/20/2014
Decision Date 11/17/2014
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
Expedited Review Yes
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