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FDA 510(k)

Conductive carbon film electrode

K-Number: K231164 · 2023-08-09

Decision Date2023-08-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Conductive carbon film electrode is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K231164. 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 Conductive carbon film electrode?

Conductive carbon film electrode is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K231164.

When did Conductive carbon film electrode receive FDA 510(k) clearance?

Conductive carbon film electrode received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231164.

Who is the listed applicant for Conductive carbon film electrode?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Conductive carbon film electrode?

The FDA product code for Conductive carbon film electrode is GXY.

Other records listing Guangzhou Xinbo Electronic 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.

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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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