FDA 510(k)

智慧守護技術；預測性低血糖技術

K 號：K251217 · 2025-08-29

決定日期2025-08-29

產品代碼QJI

諮詢委員會CH

決定相當於

器材摘要

SmartGuard technology; Predictive Low Glucose technology 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 2025-08-29 under 510(k) number K251217. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartGuard technology; Predictive Low Glucose technology?

SmartGuard technology; Predictive Low Glucose technology is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K251217.

When did SmartGuard technology; Predictive Low Glucose technology receive FDA 510(k) clearance?

SmartGuard technology; Predictive Low Glucose technology received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251217.

Who is the listed applicant for SmartGuard technology; Predictive Low Glucose technology?

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 SmartGuard technology; Predictive Low Glucose technology?

The FDA product code for SmartGuard technology; Predictive Low Glucose technology is QJI.

其他以 Medtronic Minimed, Inc. 為申請人之記錄

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相關器械（代碼：QJI）

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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