FDA 510(k)

Vybe RF II

Número K: K241535 · 2024-09-25

Data da decisão2024-09-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vybe RF II is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K241535. 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 Vybe RF II?

Vybe RF II is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K241535.

When did Vybe RF II receive FDA 510(k) clearance?

Vybe RF II received FDA 510(k) clearance on 2024-09-25, under 510(k) number K241535.

Who is the listed applicant for Vybe RF II?

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

What is the FDA product code for Vybe RF II?

The FDA product code for Vybe RF II is GEI.

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Fonte oficial

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