FDA 510(k)

Conductive Silicone Rubber Electrode

Número K: K231167 · 2023-08-09

RequerenteGuangzhou Xinbo Electronic Co., Ltd.

Data da decisão2023-08-09

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Conductive Silicone Rubber Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K231167. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Conductive Silicone Rubber Electrode?

Conductive Silicone Rubber Electrode is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K231167.

When did Conductive Silicone Rubber Electrode receive FDA 510(k) clearance?

Conductive Silicone Rubber Electrode received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231167.

Who is the listed applicant for Conductive Silicone Rubber Electrode?

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

What is the FDA product code for Conductive Silicone Rubber Electrode?

The FDA product code for Conductive Silicone Rubber Electrode is GXY.

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