FDA 510(k)

Control-IQ+ 技术

K号: K250798 · 2025-05-21

决定日期2025-05-21

产品代码QJI

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决定实质等同

器械摘要

Control-IQ+ technology is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K250798. 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 Control-IQ+ technology?

Control-IQ+ technology is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K250798.

When did Control-IQ+ technology receive FDA 510(k) clearance?

Control-IQ+ technology received FDA 510(k) clearance on 2025-05-21, under 510(k) number K250798.

Who is the listed applicant for Control-IQ+ technology?

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

What is the FDA product code for Control-IQ+ technology?

The FDA product code for Control-IQ+ technology is QJI.

列明Tandem Diabetes Care, 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。

K260429Control-IQ+ 技术 K253074Tandem Mobi 胰岛素泵，具有互操作性技术 K250792t:slim X2 胰岛素泵，具备互操作性技术 K243823Control-IQ+ 技术 K241078Tandem Mobi 胰岛素泵，具有互操作性技术 K240309Tandem Mobi 胰岛素泵，具有互操作性技术

查看所有 18 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。