FDA 510(k)

SmartGuard技术；预测性低血糖技术

K号: K253585 · 2026-01-14

决定日期2026-01-14

产品代码QJI

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

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 2026-01-14 under 510(k) number K253585. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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 2026-01-14. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K253585.

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 2026-01-14, under 510(k) number K253585.

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.

列明Medtronic Minimed, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253743MiniMed Flex 泵 K253470MiniMed 780G 胰岛素泵（MMT-1884）；MiniMed 780G 胰岛素泵套装（MMT-1894）K251217SmartGuard技术；预测性低血糖技术 K251032MiniMed 780G 胰岛素泵 K210714延长储液器

官方来源

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