FDA 510(k)

扩展储液器；MiniMed储液器

K号: K241622 · 2024-07-02

决定日期2024-07-02

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

Extended Reservoir; MiniMed Reservoir is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K241622. 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 Extended Reservoir; MiniMed Reservoir?

Extended Reservoir; MiniMed Reservoir is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Medtronic Minimed. The 510(k) number is K241622.

When did Extended Reservoir; MiniMed Reservoir receive FDA 510(k) clearance?

Extended Reservoir; MiniMed Reservoir received FDA 510(k) clearance on 2024-07-02, under 510(k) number K241622.

Who is the listed applicant for Extended Reservoir; MiniMed Reservoir?

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

What is the FDA product code for Extended Reservoir; MiniMed Reservoir?

The FDA product code for Extended Reservoir; MiniMed Reservoir is LZG.

列明Medtronic Minimed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。

K261962SmartGuard技术；预测性低血糖技术 K253701SmartGuard技术；预测性低血糖技术 K253512MiniMed Go 应用 K242775InPen系统应用（MMT-8060（iOS），MMT-8061（Android））K160860MiniMed Quick-serter

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。