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FDA 510(k)

設備袋

K 號：K172578 · 2017-12-07

申請人Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
決定日期2017-12-07
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Equipment Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172578. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Equipment Pouch?

Equipment Pouch is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K172578.

When did Equipment Pouch receive FDA 510(k) clearance?

Equipment Pouch received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172578.

Who is the listed applicant for Equipment Pouch?

The FDA 510(k) record lists Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Equipment Pouch?

The FDA product code for Equipment Pouch is GCJ.

相關臨床試驗

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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其他以 Wickimed (Huizhou) Medical Equipment Manufacturing 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：GCJ）

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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