FDA 510(k)

BioHPP - breCAM.BioHPP

K号: K152113 · 2016-07-21

决定日期2016-07-21

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

BioHPP - breCAM.BioHPP is the device name listed in this FDA 510(k) record. The listed applicant is Bredent GmbH & Co. KG. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K152113. 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 BioHPP - breCAM.BioHPP?

BioHPP - breCAM.BioHPP is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Bredent GmbH & Co. KG. The 510(k) number is K152113.

When did BioHPP - breCAM.BioHPP receive FDA 510(k) clearance?

BioHPP - breCAM.BioHPP received FDA 510(k) clearance on 2016-07-21, under 510(k) number K152113.

Who is the listed applicant for BioHPP - breCAM.BioHPP?

The FDA 510(k) record lists Bredent GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioHPP - breCAM.BioHPP?

The FDA product code for BioHPP - breCAM.BioHPP is EBF.

列明Bredent GmbH & Co. KG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。

K240735visio.lign 颜色，visio.lign 防护罩

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。