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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 the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Dongzhi Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-22 under 510(k) 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. The listed applicant is Shaoxing Dongzhi Electrical Technology Co., Ltd.. The 510(k) number is K180773.

When did Reusable and Self-Adhesive Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Reusable and Self-Adhesive Electrodes?

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

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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Related Devices (Code: GXY)

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Official Source

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