FDA 510(k)

Adhesive Electrodes

K-Number: K160138 · 2016-08-11

Decision Date2016-08-11

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Adhesive Electrodes is a medical device manufactured by Gmdasz Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2016-08-11 under approval number K160138. 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 Adhesive Electrodes?

Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Gmdasz Manufacturing Co., Ltd.. The 510(k) number is K160138.

When was Adhesive Electrodes approved by the FDA?

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

What company makes Adhesive Electrodes?

Adhesive Electrodes is manufactured by Gmdasz Manufacturing Co., Ltd..

What is the FDA product code for Adhesive Electrodes?

The FDA product code for Adhesive Electrodes is GXY.

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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.