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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 computerized cognitive assessment aid
De Novo Number DEN130033
Device Name COGNIVUE
Requester
cerebral assessment systems, inc
10 pond view drive
pittsford,  NY  14534
Contact charles j duffy
Regulation Number882.1470
Classification Product Code
PKQ  
Date Received06/12/2013
Decision Date 06/05/2015
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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