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FDA 510(k)

icobrain-ctp

K号: K192962 · 2020-02-28

申请人Icometrix NV
决定日期2020-02-28
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

icobrain-ctp is the device name listed in this FDA 510(k) record. The listed applicant is Icometrix NV. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K192962. 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 icobrain-ctp?

icobrain-ctp is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Icometrix NV. The 510(k) number is K192962.

When did icobrain-ctp receive FDA 510(k) clearance?

icobrain-ctp received FDA 510(k) clearance on 2020-02-28, under 510(k) number K192962.

Who is the listed applicant for icobrain-ctp?

The FDA 510(k) record lists Icometrix NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for icobrain-ctp?

The FDA product code for icobrain-ctp is LLZ.

相关临床试验

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列明Icometrix NV为申报人的其他记录

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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。

官方来源

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