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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 oculomotor assessment aid
De Novo Number DEN170091
Device Name EyeBOX
Requester
oculogica, inc.
33 irving place
new york,  NY  10003
Contact rosina samadani
Regulation Number882.1455
Classification Product Code
QEA  
Date Received12/22/2017
Decision Date 12/28/2018
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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