FDA 510(k)

VARIOunite

K号: K160244 · 2016-06-02

决定日期2016-06-02

产品代码NHA

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决定实质等同

器械摘要

VARIOunite is the device name listed in this FDA 510(k) record. The listed applicant is Thommen Medical AG. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K160244. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VARIOunite?

VARIOunite is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Thommen Medical AG. The 510(k) number is K160244.

When did VARIOunite receive FDA 510(k) clearance?

VARIOunite received FDA 510(k) clearance on 2016-06-02, under 510(k) number K160244.

Who is the listed applicant for VARIOunite?

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

What is the FDA product code for VARIOunite?

The FDA product code for VARIOunite is NHA.

列明Thommen Medical AG为申报人的其他记录

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。

K171795托姆森植入系统 K151984Thommen CAD/CAM牙根桩

相关器械（代码：NHA）

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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