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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 evoked photon image capture device
De Novo Number DEN150004
Device Name EPIC ClearView System
Requester
epic research & diagnostics, inc.
7659 e pinnacle peak rd. suite 115
scottsdale,  AZ  85255
Contact nancy rizzo
Regulation Number882.1561
Classification Product Code
PNA  
Date Received01/13/2015
Decision Date 07/15/2016
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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