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FDA 510(k)

Basal-IQ 技术

K号: K193483 · 2020-02-28

申请人Tandem Diabetes Care, Inc.
决定日期2020-02-28
产品代码QJS
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

Basal-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 2020-02-28 under 510(k) number K193483. The device is classified under product code QJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Basal-IQ Technology?

Basal-IQ Technology is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K193483.

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

Basal-IQ Technology received FDA 510(k) clearance on 2020-02-28, under 510(k) number K193483.

Who is the listed applicant for Basal-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 Basal-IQ Technology?

The FDA product code for Basal-IQ Technology is QJS.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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

在 FDA 数据库中查看 →

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。

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