FDA.reportPublic FDA data

510(k) DEN170091

Device
EyeBOX
Applicant
Oculogica, Inc.
510(k) number
DEN170091
Product code
QEA
Decision
Unknown (DENG)
Decision date
2018-12-28
Date received
2017-12-22
Regulation
882.1455
Classification name
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K191183EyeBOXOculogica, Inc.2019-07-31