FDA 510(k)

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

Número K: K153019 · 2016-03-21

Data da decisão2016-03-21

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K153019. 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 Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes?

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Bio Protech, Inc.. The 510(k) number is K153019.

When did Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes receive FDA 510(k) clearance?

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes received FDA 510(k) clearance on 2016-03-21, under 510(k) number K153019.

Who is the listed applicant for Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes?

The FDA 510(k) record lists Bio Protech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes?

The FDA product code for Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes is GXY.

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Dispositivos Relacionados (Código: GXY)

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Fonte oficial

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