FDA 510(k)

InPen 系統應用程式 (MMT-8060 (iOS), MMT-8061 (Android))

K 號：K242775 · 2024-11-12

決定日期2024-11-12

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242775. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Medtronic Minimed. The 510(k) number is K242775.

When did InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) receive FDA 510(k) clearance?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242775.

Who is the listed applicant for InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

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 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

The FDA product code for InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is NDC.

其他以 Medtronic Minimed 為申請人之記錄

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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 K241622延長式儲液器；迷你美德儲液器 K160860迷你美迪快速設置器

相關器械（代碼：NDC）

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。

K254102GlucommanderGlytec, LLC K260910EndoTool IV雲端 1.0Glooko, Inc.K253512迷你美迪 Go AppMedtronic Minimed K253281上醫材Updoc, Inc.K252104T1D1Comerge AG K241088EndoTool IV (3.1)Monarch Medical Technologies

官方來源

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