FDA 510(k)

托姆森植入系统

K号: K171795 · 2017-09-29

决定日期2017-09-29

产品代码DZE

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决定实质等同

器械摘要

Thommen Implant System 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 2017-09-29 under 510(k) number K171795. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Thommen Implant System?

Thommen Implant System is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Thommen Medical AG. The 510(k) number is K171795.

When did Thommen Implant System receive FDA 510(k) clearance?

Thommen Implant System received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171795.

Who is the listed applicant for Thommen Implant System?

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 Thommen Implant System?

The FDA product code for Thommen Implant System is DZE.

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。

K160244VARIOunite K151984Thommen CAD/CAM牙根桩

官方来源

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