FDA 510(k)

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

N.º K: K153019 · 2016-03-21

Fecha de decisión2016-03-21

Código de productoGXY

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Copa MRI/CT (Modelos 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Copa MRI/CT-set (Modelos 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Copa MRI/CT-mini set (Modelos 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR Conditional Cup ElectrodesTechnomed Europe

Fuente oficial

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