FDA 510(k)

分裝設備

K 號：K182819 · 2019-12-02

決定日期2019-12-02

產品代碼LHI

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Decanting Device is the device name listed in this FDA 510(k) record. The listed applicant is Gcmedica Enterprise Ltd.(Wuxi). It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K182819. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Decanting Device?

Decanting Device is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Gcmedica Enterprise Ltd.(Wuxi). The 510(k) number is K182819.

When did Decanting Device receive FDA 510(k) clearance?

Decanting Device received FDA 510(k) clearance on 2019-12-02, under 510(k) number K182819.

Who is the listed applicant for Decanting Device?

The FDA 510(k) record lists Gcmedica Enterprise Ltd.(Wuxi) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Decanting Device?

The FDA product code for Decanting Device is LHI.

其他以 Gcmedica Enterprise Ltd.(Wuxi) 為申請人之記錄

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K251882子宮吸引器組

相關器械（代碼：LHI）

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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