FDA 510(k)

TAURUS C1

K号: K151996 · 2016-01-22

决定日期2016-01-22

产品代码EIA

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

TAURUS C1 is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Company, Ltd.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151996. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TAURUS C1?

TAURUS C1 is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Shinhung Company, Ltd.. The 510(k) number is K151996.

When did TAURUS C1 receive FDA 510(k) clearance?

TAURUS C1 received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151996.

Who is the listed applicant for TAURUS C1?

The FDA 510(k) record lists Shinhung Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAURUS C1?

The FDA product code for TAURUS C1 is EIA.

列明Shinhung Company, Ltd.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。

K213749G7，牙科手术单元及附件

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。