FDA 510(k)

Liebel-Flarsheim IBP转移套装

K号: K193010 · 2020-11-18

决定日期2020-11-18

产品代码PQH

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Liebel-Flarsheim IBP Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Liebel-Flarsheim Company, LLC. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K193010. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Liebel-Flarsheim IBP Transfer Set?

Liebel-Flarsheim IBP Transfer Set is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Liebel-Flarsheim Company, LLC. The 510(k) number is K193010.

When did Liebel-Flarsheim IBP Transfer Set receive FDA 510(k) clearance?

Liebel-Flarsheim IBP Transfer Set received FDA 510(k) clearance on 2020-11-18, under 510(k) number K193010.

Who is the listed applicant for Liebel-Flarsheim IBP Transfer Set?

The FDA 510(k) record lists Liebel-Flarsheim Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liebel-Flarsheim IBP Transfer Set?

The FDA product code for Liebel-Flarsheim IBP Transfer Set is PQH.

列明Liebel-Flarsheim Company, LLC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。

K152361OptiOne 单头对比剂输送系统带底座；带吊顶悬挂；注射器，OptiOne 基础系统

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。