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510(k) K191183

Device
EyeBOX
Applicant
Oculogica, Inc.
510(k) number
K191183
Product code
QEA  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-31
Date received
2019-05-02
Regulation
882.1455
Classification name
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rosina Samadani
Address
33 Irving Pl. New York NY US 10003 10003

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242116EyeBOX EBX-4.1Oculogica, Inc.2025-04-04
K212310EyeBOX (Model EBX-4)Oculogica, Inc.2021-12-22
K202927EYE-SYNCSyncthink, Inc.2021-10-02
K201841EyeBOXOculogica, Inc.2020-09-06
DEN170091EyeBOXOculogica, Inc.2018-12-28

Legacy Summary#

summary

FDA Review#

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