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FDA 510(k)

EyeBOX

K-Number: K191183 · 2019-07-31

ApplicantOculogica, Inc.
Decision Date2019-07-31
Product CodeQEA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EyeBOX is a medical device manufactured by Oculogica, Inc.. It received FDA 510(k) clearance on 2019-07-31 under approval number K191183. The device is classified under product code QEA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EyeBOX?

EyeBOX is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Oculogica, Inc.. The 510(k) number is K191183.

When was EyeBOX approved by the FDA?

EyeBOX received FDA 510(k) clearance on 2019-07-31, under approval number K191183.

What company makes EyeBOX?

EyeBOX is manufactured by Oculogica, Inc..

What is the FDA product code for EyeBOX?

The FDA product code for EyeBOX is QEA.

Other Devices by Oculogica, Inc.

DEN170091EyeBOX K201841EyeBOX K212310EyeBOX (Model EBX-4) K242116EyeBOX EBX-4.1

Related Devices (Code: QEA)

DEN170091EyeBOXOculogica, Inc. K201841EyeBOXOculogica, Inc. K212310EyeBOX (Model EBX-4)Oculogica, Inc. K202927EYE-SYNCSyncthink, Inc. K242116EyeBOX EBX-4.1Oculogica, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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