FDA 510(k)

延長式儲液器；迷你美德儲液器

K 號：K241622 · 2024-07-02

決定日期2024-07-02

產品代碼LZG

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

Extended Reservoir; MiniMed Reservoir is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K241622. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Extended Reservoir; MiniMed Reservoir?

Extended Reservoir; MiniMed Reservoir is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Medtronic Minimed. The 510(k) number is K241622.

When did Extended Reservoir; MiniMed Reservoir receive FDA 510(k) clearance?

Extended Reservoir; MiniMed Reservoir received FDA 510(k) clearance on 2024-07-02, under 510(k) number K241622.

Who is the listed applicant for Extended Reservoir; MiniMed Reservoir?

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 Extended Reservoir; MiniMed Reservoir?

The FDA product code for Extended Reservoir; MiniMed Reservoir is LZG.

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))K160860迷你美迪快速設置器

相關器械（代碼：LZG）

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。

K262153Pivot 胰島素輸送系統Modular Medical, Inc.K253534Pivot 胰島素輸送系統Modular Medical K240158模組化醫療 MODD1 胰島素輸送系統Modular Medical, Inc.K223372Omnipod GO 胰島素輸送裝置Insulet Corporation K210714延長式儲存器Medtronic Minimed, Inc.K211575Omnipod® 胰島素管理系統，Omnipod DASH® 胰島素管理系統Insulet Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。