FDA 510(k)

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

K-Number: K153019 · 2016-03-21

Decision Date2016-03-21

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related Devices (Code: GXY)

K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 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 K252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.