FDA 510(k)

B 配药线

K号: K203674 · 2021-09-27

决定日期2021-09-27

产品代码LHI

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

B Dispensing Line is the device name listed in this FDA 510(k) record. The listed applicant is Aea Srl. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K203674. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the B Dispensing Line?

B Dispensing Line is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Aea Srl. The 510(k) number is K203674.

When did B Dispensing Line receive FDA 510(k) clearance?

B Dispensing Line received FDA 510(k) clearance on 2021-09-27, under 510(k) number K203674.

Who is the listed applicant for B Dispensing Line?

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

What is the FDA product code for B Dispensing Line?

The FDA product code for B Dispensing Line is LHI.

列明Aea Srl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。

K192770S 配送线

相关器械（代码：LHI）

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。

K252987ADRx® 混合设备Epic Medical Pte. , Ltd.K260301药瓶适配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline 袋式过滤器Medline Industries, LP K251715FlowArt® 安瓿瓶接入通风装置Asset Medikal K251676Medline Microtek C-Flo 瓶式过滤器，无菌（2000S）；Medline Microtek 瓶式过滤器 II，无菌（2002S）；Medline Microtek 瓶式过滤器，无菌（2006S）；Medline Microtek 转移装置，无菌（2008S）Microtek Medical, LLC K243404HyHub™ 和 HyHub™ Duo 瓶盖访问设备Takeda Pharmaceuticals

官方来源

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