FDA 510(k)

迷你美780G胰島素針筒

K 號：K251032 · 2025-07-01

決定日期2025-07-01

產品代碼QFG

諮詢委員會CH

決定相當於

器材摘要

MiniMed 780G insulin pump is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed, Inc.. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K251032. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MiniMed 780G insulin pump?

MiniMed 780G insulin pump is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K251032.

When did MiniMed 780G insulin pump receive FDA 510(k) clearance?

MiniMed 780G insulin pump received FDA 510(k) clearance on 2025-07-01, under 510(k) number K251032.

Who is the listed applicant for MiniMed 780G insulin pump?

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

What is the FDA product code for MiniMed 780G insulin pump?

The FDA product code for MiniMed 780G insulin pump is QFG.

其他以 Medtronic Minimed, Inc. 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。

K253743迷你美德Flex泵 K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)K253585智慧守護技術；預測性低血糖技術 K251217智慧守護技術；預測性低血糖技術 K210714延長式儲存器

相關器械（代碼：QFG）

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。

K260001薄荷ACE泵Beta Bionics, Inc.K261672twiist自動胰島素輸送（AID）系統Deka Research and Development K253976iLet ACE 泵Beta Bionics, Inc.K253743迷你美德Flex泵Medtronic Minimed, Inc.K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi 胰島素針筒配互操作性技術Tandem Diabetes Care, Inc.

官方來源

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