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FDA 510(k)

Perfit CL

K-Number: K223029 · 2023-06-20

Decision Date2023-06-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Perfit CL is a medical device manufactured by Vatech Mcis Co., Ltd.. It received FDA 510(k) clearance on 2023-06-20 under approval number K223029. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perfit CL?

Perfit CL is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Vatech Mcis Co., Ltd.. The 510(k) number is K223029.

When was Perfit CL approved by the FDA?

Perfit CL received FDA 510(k) clearance on 2023-06-20, under approval number K223029.

What company makes Perfit CL?

Perfit CL is manufactured by Vatech Mcis Co., Ltd..

What is the FDA product code for Perfit CL?

The FDA product code for Perfit CL is EIH.

Related Devices (Code: EIH)

Official Source

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