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FDA 510(k)

Vatech Clismile

K-Number: K220689 · 2022-05-06

Decision Date2022-05-06
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vatech Clismile is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under approval number K220689. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vatech Clismile?

Vatech Clismile is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K220689.

When was Vatech Clismile approved by the FDA?

Vatech Clismile received FDA 510(k) clearance on 2022-05-06, under approval number K220689.

What company makes Vatech Clismile?

Vatech Clismile is manufactured by Rayence Co., Ltd..

What is the FDA product code for Vatech Clismile?

The FDA product code for Vatech Clismile is NJM.

Other Devices by Rayence Co., Ltd.

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Related Devices (Code: NJM)

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.