FDA 510(k)

Gerador de RF M-3004 Mygen M-3004

Número K: K221277 · 2022-09-02

Data da decisão2022-09-02

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is RF Medical Co., Ltd.. The 510(k) number is K221277.

When did Mygen M-3004 RF Generator M-3004 receive FDA 510(k) clearance?

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

Who is the listed applicant for Mygen M-3004 RF Generator M-3004?

The FDA 510(k) record lists RF Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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