FDA 510(k)

Mygen M-3004 RF Generator M-3004

K-Number: K221277 · 2022-09-02

Decision Date2022-09-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Mygen M-3004 RF Generator M-3004 is a medical device manufactured by RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-02 under approval number K221277. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mygen M-3004 RF Generator M-3004?

Mygen M-3004 RF Generator M-3004 is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by RF Medical Co., Ltd.. The 510(k) number is K221277.

When was Mygen M-3004 RF Generator M-3004 approved by the FDA?

Mygen M-3004 RF Generator M-3004 received FDA 510(k) clearance on 2022-09-02, under approval number K221277.

What company makes Mygen M-3004 RF Generator M-3004?

Mygen M-3004 RF Generator M-3004 is manufactured by RF Medical Co., Ltd..

What is the FDA product code for Mygen M-3004 RF Generator M-3004?

The FDA product code for Mygen M-3004 RF Generator M-3004 is GEI.

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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.