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FDA 510(k)

MFI-Cardiac

K号: K173512 · 2018-02-05

决定日期2018-02-05
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

MFI-Cardiac is the device name listed in this FDA 510(k) record. The listed applicant is Multifunctional Imaging, LLC. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K173512. 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 MFI-Cardiac?

MFI-Cardiac is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Multifunctional Imaging, LLC. The 510(k) number is K173512.

When did MFI-Cardiac receive FDA 510(k) clearance?

MFI-Cardiac received FDA 510(k) clearance on 2018-02-05, under 510(k) number K173512.

Who is the listed applicant for MFI-Cardiac?

The FDA 510(k) record lists Multifunctional Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MFI-Cardiac?

The FDA product code for MFI-Cardiac is LLZ.

相关临床试验

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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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