FDA 510(k)

Omnipod® 胰岛素管理系统，Omnipod DASH® 胰岛素管理系统

K号: K211575 · 2021-08-13

决定日期2021-08-13

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

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211575. 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 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Insulet Corporation. The 510(k) number is K211575.

When did Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System receive FDA 510(k) clearance?

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211575.

Who is the listed applicant for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?

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 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?

The FDA product code for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is LZG.

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 K232741SmartAdjust™ 技术 K231824SmartBolus 计算器 K231826Omnipod 5 ACE 泵

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官方来源

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