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FDA 510(k)

t:slim 胰岛素输送系统，t:flex 胰岛素输送系统，Tandem 设备更新器

K号: K160482 · 2016-07-13

申请人Tandem Diabetes Care, Inc.
决定日期2016-07-13
产品代码LZG
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater 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 2016-07-13 under 510(k) number K160482. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K160482.

When did t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater receive FDA 510(k) clearance?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160482.

Who is the listed applicant for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

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 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

The FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is LZG.

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 →

相关器械（代码：LZG）

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。

K262153Pivot 胰岛素输送系统Modular Medical, Inc.K253534Pivot 胰岛素输送系统Modular MedicalK240158Modular Medical MODD1 胰岛素输送系统Modular Medical, Inc.K241622扩展储液器；MiniMed储液器Medtronic MinimedK223372Omnipod GO 胰岛素输送设备Insulet CorporationK210714延长储液器Medtronic Minimed, Inc.

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。

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