FDA 510(k)

Eletródos Adesivos

Número K: K212191 · 2021-10-06

RequerenteVoncare Medical Device Co., Ltd.

Data da decisão2021-10-06

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Voncare Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-10-06 under 510(k) number K212191. 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 Adhesive Electrodes?

Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2021-10-06. The listed applicant is Voncare Medical Device Co., Ltd.. The 510(k) number is K212191.

When did Adhesive Electrodes receive FDA 510(k) clearance?

Adhesive Electrodes received FDA 510(k) clearance on 2021-10-06, under 510(k) number K212191.

Who is the listed applicant for Adhesive Electrodes?

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

What is the FDA product code for Adhesive Electrodes?

The FDA product code for Adhesive Electrodes is GXY.

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