FDA 510(k)

Calcium Bridge

K号: K153191 · 2016-02-26

决定日期2016-02-26

产品代码EBF

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

Calcium Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K153191. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Calcium Bridge?

Calcium Bridge is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Denali Corporation. The 510(k) number is K153191.

When did Calcium Bridge receive FDA 510(k) clearance?

Calcium Bridge received FDA 510(k) clearance on 2016-02-26, under 510(k) number K153191.

Who is the listed applicant for Calcium Bridge?

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

What is the FDA product code for Calcium Bridge?

The FDA product code for Calcium Bridge is EBF.

列明Denali Corporation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。

K151945Triumph 树脂阻尼器

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。