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FDA 510(k)

EyeArt

K-Number: K200667 · 2020-08-03

ApplicantEyenuk, Inc.
Decision Date2020-08-03
Product CodePIB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EyeArt is a medical device manufactured by Eyenuk, Inc.. It received FDA 510(k) clearance on 2020-08-03 under approval number K200667. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EyeArt?

EyeArt is a medical device that received FDA 510(k) clearance on 2020-08-03. It is manufactured by Eyenuk, Inc.. The 510(k) number is K200667.

When was EyeArt approved by the FDA?

EyeArt received FDA 510(k) clearance on 2020-08-03, under approval number K200667.

What company makes EyeArt?

EyeArt is manufactured by Eyenuk, Inc..

What is the FDA product code for EyeArt?

The FDA product code for EyeArt is PIB.

Other Devices by Eyenuk, Inc.

Related Devices (Code: PIB)

Official Source

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