FDA 510(k)

SmartAdjust™ 技术

K号: K232741 · 2024-05-29

决定日期2024-05-29

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

SmartAdjust(TM) technology is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K232741. 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 SmartAdjust(TM) technology?

SmartAdjust(TM) technology is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Insulet Corporation. The 510(k) number is K232741.

When did SmartAdjust(TM) technology receive FDA 510(k) clearance?

SmartAdjust(TM) technology received FDA 510(k) clearance on 2024-05-29, under 510(k) number K232741.

Who is the listed applicant for SmartAdjust(TM) technology?

The FDA 510(k) record lists Insulet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartAdjust(TM) technology?

The FDA product code for SmartAdjust(TM) technology is QJI.

列明Insulet Corporation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。

K261461Omnipod 6 算法 K251779Omnipod 5 算法 K241777SmartAdjust™ 技术 K231824SmartBolus 计算器 K231826Omnipod 5 ACE 泵 K223372Omnipod GO 胰岛素输送设备

查看所有 19 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。