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FDA 510(k)

Mailuokang Self-adhesive Electrode

K-Number: K152815 · 2016-03-08

Decision Date2016-03-08
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mailuokang Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mailuokang Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152815. 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 Mailuokang Self-adhesive Electrode?

Mailuokang Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Shenzhen Mailuokang Technology Co., Ltd.. The 510(k) number is K152815.

When did Mailuokang Self-adhesive Electrode receive FDA 510(k) clearance?

Mailuokang Self-adhesive Electrode received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152815.

Who is the listed applicant for Mailuokang Self-adhesive Electrode?

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

What is the FDA product code for Mailuokang Self-adhesive Electrode?

The FDA product code for Mailuokang Self-adhesive Electrode is GXY.

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.

Official Source

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