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FDA 510(k)

ZedView

K-Number: K200704 · 2021-05-27

ApplicantLexi Co., Ltd.
Decision Date2021-05-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZedView is a medical device manufactured by Lexi Co., Ltd.. It received FDA 510(k) clearance on 2021-05-27 under approval number K200704. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZedView?

ZedView is a medical device that received FDA 510(k) clearance on 2021-05-27. It is manufactured by Lexi Co., Ltd.. The 510(k) number is K200704.

When was ZedView approved by the FDA?

ZedView received FDA 510(k) clearance on 2021-05-27, under approval number K200704.

What company makes ZedView?

ZedView is manufactured by Lexi Co., Ltd..

What is the FDA product code for ZedView?

The FDA product code for ZedView is LLZ.

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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.

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