EyeBOX (Model EBX-4)

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Oculogica, Inc.

The following data is part of a premarket notification filed by Oculogica, Inc. with the FDA for Eyebox (model Ebx-4).

Pre-market Notification Details

Device IDK212310
510k NumberK212310
Device Name:EyeBOX (Model EBX-4)
ClassificationBrain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Applicant Oculogica, Inc. 33 Irving Place New York,  NY  10003
ContactRosina Samadani
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeQEA  
CFR Regulation Number882.1455 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-23
Decision Date2021-12-22

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