FDA 510(k)

HF Surgery Generator 400KHZ

Número K: K230194 · 2023-03-22

RequerenteRichard Wolf Medical Instruments Corporation

Data da decisão2023-03-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HF Surgery Generator 400KHZ is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K230194. 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 HF Surgery Generator 400KHZ?

HF Surgery Generator 400KHZ is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K230194.

When did HF Surgery Generator 400KHZ receive FDA 510(k) clearance?

HF Surgery Generator 400KHZ received FDA 510(k) clearance on 2023-03-22, under 510(k) number K230194.

Who is the listed applicant for HF Surgery Generator 400KHZ?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HF Surgery Generator 400KHZ?

The FDA product code for HF Surgery Generator 400KHZ is GEI.

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