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FDA 510(k)

GT5 適電與磨損膠

K 號:K212787 · 2021-11-08

決定日期2021-11-08
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

GT5 conductive & abrasive gel is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Greentek Pty , Ltd.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K212787. 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 GT5 conductive & abrasive gel?

GT5 conductive & abrasive gel is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Wuhan Greentek Pty , Ltd.. The 510(k) number is K212787.

When did GT5 conductive & abrasive gel receive FDA 510(k) clearance?

GT5 conductive & abrasive gel received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212787.

Who is the listed applicant for GT5 conductive & abrasive gel?

The FDA 510(k) record lists Wuhan Greentek Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GT5 conductive & abrasive gel?

The FDA product code for GT5 conductive & abrasive gel is GYB.

相關臨床試驗

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其他以 Wuhan Greentek Pty , 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。

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。

官方來源

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