FDA 510(k)

Control-IQ 技术

K号: K232382 · 2023-11-03

决定日期2023-11-03

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 2023-11-03 under 510(k) number K232382. 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 2023-11-03. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K232382.

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

Control-IQ Technology received FDA 510(k) clearance on 2023-11-03, under 510(k) number K232382.

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 K250798Control-IQ+ 技术 K243823Control-IQ+ 技术 K241078Tandem 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。