FDA 510(k)

Magicore Narrow System

K号: K220079 · 2022-12-14

决定日期2022-12-14

产品代码DZE

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决定实质等同

器械摘要

Magicore Narrow System is the device name listed in this FDA 510(k) record. The listed applicant is Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K220079. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Magicore Narrow System?

Magicore Narrow System is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Innobiosurg Co., Ltd.. The 510(k) number is K220079.

When did Magicore Narrow System receive FDA 510(k) clearance?

Magicore Narrow System received FDA 510(k) clearance on 2022-12-14, under 510(k) number K220079.

Who is the listed applicant for Magicore Narrow System?

The FDA 510(k) record lists Innobiosurg Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magicore Narrow System?

The FDA product code for Magicore Narrow System is DZE.

列明Innobiosurg Co., Ltd.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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