FDA 510(k)

導電矽膠電極

K 號：K231167 · 2023-08-09

決定日期2023-08-09

產品代碼GXY

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Conductive Silicone Rubber 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 K231167. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Conductive Silicone Rubber Electrode?

Conductive Silicone Rubber 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 K231167.

When did Conductive Silicone Rubber Electrode receive FDA 510(k) clearance?

Conductive Silicone Rubber Electrode received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231167.

Who is the listed applicant for Conductive Silicone Rubber 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 Silicone Rubber Electrode?

The FDA product code for Conductive Silicone Rubber Electrode is GXY.

其他以 Guangzhou Xinbo Electronic Co., Ltd. 為申請人之記錄

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相關器械（代碼：GXY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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