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FDA 510(k)

Cliniview

K号: K162799 · 2017-04-25

决定日期2017-04-25
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Cliniview is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162799. 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 Cliniview?

Cliniview is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Palodex Group OY. The 510(k) number is K162799.

When did Cliniview receive FDA 510(k) clearance?

Cliniview received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162799.

Who is the listed applicant for Cliniview?

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

What is the FDA product code for Cliniview?

The FDA product code for Cliniview is LLZ.

相关临床试验

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列明Palodex Group OY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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