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FDA 510(k)

Adhesive Electrodes

K-Number: K160138 · 2016-08-11

ApplicantGmdasz Manufacturing Co., Ltd.
Decision Date2016-08-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Gmdasz Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) 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. The listed applicant is Gmdasz Manufacturing Co., Ltd.. The 510(k) number is K160138.

When did Adhesive Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Adhesive Electrodes?

The FDA 510(k) record lists Gmdasz Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adhesive Electrodes?

The FDA product code for Adhesive Electrodes is GXY.

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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