FDA 510(k)

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K番号: K222453 · 2022-11-04

申請者Guangdong Comytens Medical Technology Co., Ltd.

決定日2022-11-04

製品コードGXY

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Comytens Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222453. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Self-adhesive Electrode?

Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Guangdong Comytens Medical Technology Co., Ltd.. The 510(k) number is K222453.

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

Self-adhesive Electrode received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222453.

Who is the listed applicant for Self-adhesive Electrode?

The FDA 510(k) record lists Guangdong Comytens Medical Technology 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.

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医療機器の概要

よくある質問

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関連機器（コード：GXY）

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