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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 for concussion
De Novo Number DEN150037
Device Name ImPACT Computerized Neurocognitive Concussion Management Aid
Requester
impact applications, inc.
2000 technology dr., suite 150
pittsburgh,  PA  15219
Contact michael zagorski
Regulation Number882.1471
Classification Product Code
POM  
Date Received08/11/2015
Decision Date 08/22/2016
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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