FDA 510(k)

Omnipod 胰岛素管理系统，Omnipod DASH 胰岛素管理系统

K号: K192659 · 2019-10-21

决定日期2019-10-21

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 2019-10-21 under 510(k) number K192659. 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 2019-10-21. The listed applicant is Insulet Corporation. The 510(k) number is K192659.

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 2019-10-21, under 510(k) number K192659.

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。

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