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FDA 510(k)

CorInsights MRI

K号: K193287 · 2020-11-20

决定日期2020-11-20
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

CorInsights MRI is the device name listed in this FDA 510(k) record. The listed applicant is Adm Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K193287. 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 CorInsights MRI?

CorInsights MRI is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Adm Diagnostics, Inc.. The 510(k) number is K193287.

When did CorInsights MRI receive FDA 510(k) clearance?

CorInsights MRI received FDA 510(k) clearance on 2020-11-20, under 510(k) number K193287.

Who is the listed applicant for CorInsights MRI?

The FDA 510(k) record lists Adm Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorInsights MRI?

The FDA product code for CorInsights MRI is LLZ.

相关临床试验

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。

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。

官方来源

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