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FDA 510(k)

Jiajian Self-Adhesive Electrode

K-Number: K192568 · 2021-02-03

ApplicantWuxi Jiajian Medical Instrument Co., Ltd.
Decision Date2021-02-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Jiajian Self-Adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K192568. 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 Jiajian Self-Adhesive Electrode?

Jiajian Self-Adhesive Electrode is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K192568.

When did Jiajian Self-Adhesive Electrode receive FDA 510(k) clearance?

Jiajian Self-Adhesive Electrode received FDA 510(k) clearance on 2021-02-03, under 510(k) number K192568.

Who is the listed applicant for Jiajian Self-Adhesive Electrode?

The FDA 510(k) record lists Wuxi Jiajian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jiajian Self-Adhesive Electrode?

The FDA product code for Jiajian Self-Adhesive Electrode is GXY.

Other records listing Wuxi Jiajian Medical Instrument Co., Ltd. as applicant

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Related Devices (Code: GXY)

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Official Source

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