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FDA 510(k)

Reusable and Self-Adhesive Electrodes

K-Number: K180773 · 2018-05-22

ApplicantShaoxing Dongzhi Electrical Technology Co., Ltd.
Decision Date2018-05-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Reusable and Self-Adhesive Electrodes is a medical device manufactured by Shaoxing Dongzhi Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-22 under approval number K180773. 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 Reusable and Self-Adhesive Electrodes?

Reusable and Self-Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2018-05-22. It is manufactured by Shaoxing Dongzhi Electrical Technology Co., Ltd.. The 510(k) number is K180773.

When was Reusable and Self-Adhesive Electrodes approved by the FDA?

Reusable and Self-Adhesive Electrodes received FDA 510(k) clearance on 2018-05-22, under approval number K180773.

What company makes Reusable and Self-Adhesive Electrodes?

Reusable and Self-Adhesive Electrodes is manufactured by Shaoxing Dongzhi Electrical Technology Co., Ltd..

What is the FDA product code for Reusable and Self-Adhesive Electrodes?

The FDA product code for Reusable and Self-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.

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