FDA 510(k)

OmniPod 胰岛素管理系统

K号: K162296 · 2017-04-18

决定日期2017-04-18

产品代码LZG

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决定实质等同

器械摘要

OmniPod 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 2017-04-18 under 510(k) number K162296. 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 Insulin Management System is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Insulet Corporation. The 510(k) number is K162296.

When did OmniPod Insulin Management System receive FDA 510(k) clearance?

OmniPod Insulin Management System received FDA 510(k) clearance on 2017-04-18, under 510(k) number K162296.

Who is the listed applicant for OmniPod 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?

The FDA product code for OmniPod 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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