FDA 510(k)

VYBE RF Electrosurgical System

Número K: K230968 · 2023-07-06

Data da decisão2023-07-06

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VYBE RF Electrosurgical System 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 2023-07-06 under 510(k) number K230968. 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 Electrosurgical System?

VYBE RF Electrosurgical System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K230968.

When did VYBE RF Electrosurgical System receive FDA 510(k) clearance?

VYBE RF Electrosurgical System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K230968.

Who is the listed applicant for VYBE RF Electrosurgical System?

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 Electrosurgical System?

The FDA product code for VYBE RF Electrosurgical System is GEI.

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Fonte oficial

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