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FDA 510(k)

Self-adhesive Electrode

K-Number: K213879 · 2022-01-05

Decision Date2022-01-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K213879. 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 Self-adhesive Electrode?

Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K213879.

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

Self-adhesive Electrode received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213879.

Who is the listed applicant for Self-adhesive Electrode?

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

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

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

Other records listing Bozhou Rongjian Medical Appliance Co., Ltd. as applicant

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.

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.