FDA 510(k)

迷你美迪快速設置器

K 號：K160860 · 2016-09-22

決定日期2016-09-22

產品代碼KZH

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

MiniMed Quick-serter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K160860. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MiniMed Quick-serter?

MiniMed Quick-serter is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Medtronic Minimed. The 510(k) number is K160860.

When did MiniMed Quick-serter receive FDA 510(k) clearance?

MiniMed Quick-serter received FDA 510(k) clearance on 2016-09-22, under 510(k) number K160860.

Who is the listed applicant for MiniMed Quick-serter?

The FDA 510(k) record lists Medtronic Minimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniMed Quick-serter?

The FDA product code for MiniMed Quick-serter is KZH.

其他以 Medtronic Minimed 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。

K261962智能守護技術；預測性低血糖技術 K253701智能守護技術；預測性低血糖技術 K253512迷你美迪 Go App K242775InPen 系統應用程式 (MMT-8060 (iOS), MMT-8061 (Android))K241622延長式儲液器；迷你美德儲液器

相關器械（代碼：KZH）

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。

K243232握合夥伴Synthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies Corporation K163400Orbit 插入器Ypsomed AG

官方來源

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