FDA 510(k)

Eletródos Adesivos

Número K: K160138 · 2016-08-11

RequerenteGmdasz Manufacturing Co., Ltd.

Data da decisão2016-08-11

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 Gmdasz Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K160138. 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 2016-08-11. The listed applicant is Gmdasz Manufacturing Co., Ltd.. The 510(k) number is K160138.

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

Adhesive Electrodes received FDA 510(k) clearance on 2016-08-11, under 510(k) number K160138.

Who is the listed applicant for Adhesive Electrodes?

The FDA 510(k) record lists Gmdasz Manufacturing 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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