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FDA 510(k)

Uroview FD

K号: K161019 · 2016-08-17

决定日期2016-08-17
产品代码JAA
咨询委员会RA
决定实质等同

器械摘要

Uroview FD is the device name listed in this FDA 510(k) record. The listed applicant is Pausch Medical GmbH. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K161019. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Uroview FD?

Uroview FD is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Pausch Medical GmbH. The 510(k) number is K161019.

When did Uroview FD receive FDA 510(k) clearance?

Uroview FD received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161019.

Who is the listed applicant for Uroview FD?

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

What is the FDA product code for Uroview FD?

The FDA product code for Uroview FD is JAA.

相关临床试验

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列明Pausch Medical GmbH为申报人的其他记录

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相关器械(代码:JAA)

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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