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FDA 510(k)

RightEye Vision System

K-Number: K181771 · 2018-09-28

ApplicantRighteye, LLC
Decision Date2018-09-28
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RightEye Vision System is a medical device manufactured by Righteye, LLC. It received FDA 510(k) clearance on 2018-09-28 under approval number K181771. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RightEye Vision System?

RightEye Vision System is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Righteye, LLC. The 510(k) number is K181771.

When was RightEye Vision System approved by the FDA?

RightEye Vision System received FDA 510(k) clearance on 2018-09-28, under approval number K181771.

What company makes RightEye Vision System?

RightEye Vision System is manufactured by Righteye, LLC.

What is the FDA product code for RightEye Vision System?

The FDA product code for RightEye Vision System is GWN.

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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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