FDA.reportPublic FDA data

510(k) K242116

Device
EyeBOX EBX-4.1
Applicant
Oculogica, Inc.
510(k) number
K242116
Product code
QEA
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-04
Date received
2024-07-19
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
N

Applicant Contact#

Contact
Rosina Samadani
Address
1477 S. Knowles Ave. #110f New Richmond WI US 54017 54017

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
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
DEN170091EyeBOXOculogica, Inc.2018-12-28