FDA 510(k)

DR-HO'S 電療導電膠

K 號：K200402 · 2020-11-25

決定日期2020-11-25

產品代碼GYB

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

DR-HO'S Electro Therapy Conductive Gel 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 2020-11-25 under 510(k) number K200402. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DR-HO'S Electro Therapy Conductive Gel?

DR-HO'S Electro Therapy Conductive Gel is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K200402.

When did DR-HO'S Electro Therapy Conductive Gel receive FDA 510(k) clearance?

DR-HO'S Electro Therapy Conductive Gel received FDA 510(k) clearance on 2020-11-25, under 510(k) number K200402.

Who is the listed applicant for DR-HO'S Electro Therapy Conductive Gel?

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 DR-HO'S Electro Therapy Conductive Gel?

The FDA product code for DR-HO'S Electro Therapy Conductive Gel is GYB.

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

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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相關器械（代碼：GYB）

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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官方來源

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