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FDA 510(k)

3DIEMME RealGUIDE

K号: K173041 · 2018-12-20

决定日期2018-12-20
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

3DIEMME RealGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is 3Diemme , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K173041. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3DIEMME RealGUIDE?

3DIEMME RealGUIDE is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is 3Diemme , Ltd.. The 510(k) number is K173041.

When did 3DIEMME RealGUIDE receive FDA 510(k) clearance?

3DIEMME RealGUIDE received FDA 510(k) clearance on 2018-12-20, under 510(k) number K173041.

Who is the listed applicant for 3DIEMME RealGUIDE?

The FDA 510(k) record lists 3Diemme , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DIEMME RealGUIDE?

The FDA product code for 3DIEMME RealGUIDE is LLZ.

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相关器械(代码:LLZ)

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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