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FDA 510(k)

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

K-Number: K153019 · 2016-03-21

ApplicantBio Protech, Inc.
Decision Date2016-03-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes is a medical device manufactured by Bio Protech, Inc.. It received FDA 510(k) clearance on 2016-03-21 under approval 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. It is manufactured by Bio Protech, Inc.. The 510(k) number is K153019.

When was Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes approved by the FDA?

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

What company makes Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes?

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes is manufactured by Bio Protech, Inc..

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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Official Source

View on FDA Database →

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

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