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510(k) K202927

Device
EYE-SYNC
Applicant
SyncThink, Inc.
510(k) number
K202927
Product code
QEA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-02
Date received
2020-09-29
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
Dan Beeler
Address
2172 Staunton Ct. Palo Alto CA US 94306 94306

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
K201841EyeBOXOculogica, Inc.2020-09-06
K191183EyeBOXOculogica, Inc.2019-07-31
DEN170091EyeBOXOculogica, Inc.2018-12-28

Legacy Summary#

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FDA Review#

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