FDA 510(k)

15mm 藥品針筒適配器

K 號：K171796 · 2017-10-12

決定日期2017-10-12

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

Vial Adapter 15mm is the device name listed in this FDA 510(k) record. The listed applicant is Medimop Medical Project , Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171796. 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 Vial Adapter 15mm?

Vial Adapter 15mm is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Medimop Medical Project , Ltd.. The 510(k) number is K171796.

When did Vial Adapter 15mm receive FDA 510(k) clearance?

Vial Adapter 15mm received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171796.

Who is the listed applicant for Vial Adapter 15mm?

The FDA 510(k) record lists Medimop Medical Project , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial Adapter 15mm?

The FDA product code for Vial Adapter 15mm is LHI.

其他以 Medimop Medical Project , 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。

K170095Vial2Bag 直接連接

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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官方來源

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