EyeBOX (Model EBX-4)
K-Number: K212310 · 2021-12-22
ApplicantOculogica, Inc.
Decision Date2021-12-22
Product CodeQEA
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EyeBOX (Model EBX-4) is a medical device manufactured by Oculogica, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K212310. 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 (Model EBX-4)?
EyeBOX (Model EBX-4) is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Oculogica, Inc.. The 510(k) number is K212310.
When was EyeBOX (Model EBX-4) approved by the FDA?
EyeBOX (Model EBX-4) received FDA 510(k) clearance on 2021-12-22, under approval number K212310.
What company makes EyeBOX (Model EBX-4)?
EyeBOX (Model EBX-4) is manufactured by Oculogica, Inc..
What is the FDA product code for EyeBOX (Model EBX-4)?
The FDA product code for EyeBOX (Model EBX-4) is QEA.
Other Devices by Oculogica, Inc.
Related Devices (Code: QEA)
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.