FDA 510(k)

Eletródo Adesivo

Número K: K210448 · 2021-08-31

RequerenteShaoxing Yingtuo Healthcare Co., Ltd.

Data da decisão2021-08-31

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Yingtuo Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K210448. 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 Electrode?

Adhesive Electrode is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Shaoxing Yingtuo Healthcare Co., Ltd.. The 510(k) number is K210448.

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

Adhesive Electrode received FDA 510(k) clearance on 2021-08-31, under 510(k) number K210448.

Who is the listed applicant for Adhesive Electrode?

The FDA 510(k) record lists Shaoxing Yingtuo Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adhesive Electrode?

The FDA product code for Adhesive Electrode is GXY.

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