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FDA 510(k)

ThermArt (Model IR-EFT)

K-Number: K202481 · 2021-09-28

Decision Date2021-09-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ThermArt (Model IR-EFT) is a medical device manufactured by Comper Chuangxiang (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under approval number K202481. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThermArt (Model IR-EFT)?

ThermArt (Model IR-EFT) is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Comper Chuangxiang (Beijing) Technology Co., Ltd.. The 510(k) number is K202481.

When was ThermArt (Model IR-EFT) approved by the FDA?

ThermArt (Model IR-EFT) received FDA 510(k) clearance on 2021-09-28, under approval number K202481.

What company makes ThermArt (Model IR-EFT)?

ThermArt (Model IR-EFT) is manufactured by Comper Chuangxiang (Beijing) Technology Co., Ltd..

What is the FDA product code for ThermArt (Model IR-EFT)?

The FDA product code for ThermArt (Model IR-EFT) is FLL.

Other Devices by Comper Chuangxiang (Beijing) Technology Co., Ltd.

Related Devices (Code: FLL)

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.