FDA 510(k)

AMICUS 分离系统，AMICUS 分离系统；翻新

K号: K162462 · 2016-11-23

决定日期2016-11-23

产品代码GKT

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

AMICUS Separator System, AMICUS Separator System; Refurbished is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi USA,Llc. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K162462. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AMICUS Separator System, AMICUS Separator System; Refurbished?

AMICUS Separator System, AMICUS Separator System; Refurbished is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Fresenius Kabi USA,Llc. The 510(k) number is K162462.

When did AMICUS Separator System, AMICUS Separator System; Refurbished receive FDA 510(k) clearance?

AMICUS Separator System, AMICUS Separator System; Refurbished received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162462.

Who is the listed applicant for AMICUS Separator System, AMICUS Separator System; Refurbished?

The FDA 510(k) record lists Fresenius Kabi USA,Llc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMICUS Separator System, AMICUS Separator System; Refurbished?

The FDA product code for AMICUS Separator System, AMICUS Separator System; Refurbished is GKT.

列明Fresenius Kabi USA,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。

K180615AMICUS 分离系统，AMICUS 交换包 - 治疗品，废物转移套装，带排气针和卢瑞适配器的血液成分过滤器套装

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