EyeBOX

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Oculogica, Inc.

The following data is part of a De Novo classification by Oculogica, Inc. with the FDA for Eyebox.

Pre-market Notification Details

DeNovo IDDEN170091
Device Name:EyeBOX
ClassificationBrain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Applicant Oculogica, Inc. 33 Irving Place New York,  NY  10003
ContactRosina Samadani
Product CodeQEA  
CFR Regulation Number882.1455 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypeDirect
Date Received2017-12-22
Decision Date2018-12-28
Reclassification Order:Reclassification Order

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