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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
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Expedited Review Yes
Predetermined Change
Control Plan Authorized		 No
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