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FDA 510(k)

Reusable and Self-Adhesive Electrodes

Número K: K180773 · 2018-05-22

RequerenteShaoxing Dongzhi Electrical Technology Co., Ltd.
Data da decisão2018-05-22
Código do produtoGXY
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reusable and Self-Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Dongzhi Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-22 under 510(k) number K180773. 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 Reusable and Self-Adhesive Electrodes?

Reusable and Self-Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2018-05-22. The listed applicant is Shaoxing Dongzhi Electrical Technology Co., Ltd.. The 510(k) number is K180773.

When did Reusable and Self-Adhesive Electrodes receive FDA 510(k) clearance?

Reusable and Self-Adhesive Electrodes received FDA 510(k) clearance on 2018-05-22, under 510(k) number K180773.

Who is the listed applicant for Reusable and Self-Adhesive Electrodes?

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

What is the FDA product code for Reusable and Self-Adhesive Electrodes?

The FDA product code for Reusable and Self-Adhesive Electrodes is GXY.

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