FDA 510(k)

Racz Neurostat RF Generator

Número K: K232632 · 2024-05-24

Data da decisão2024-05-24

Código do produtoGXD

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Racz Neurostat RF Generator is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K232632. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Racz Neurostat RF Generator?

Racz Neurostat RF Generator is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Epimed International. The 510(k) number is K232632.

When did Racz Neurostat RF Generator receive FDA 510(k) clearance?

Racz Neurostat RF Generator received FDA 510(k) clearance on 2024-05-24, under 510(k) number K232632.

Who is the listed applicant for Racz Neurostat RF Generator?

The FDA 510(k) record lists Epimed International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Racz Neurostat RF Generator?

The FDA product code for Racz Neurostat RF Generator is GXD.

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