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FDA 510(k)

i3 ONE（203100-S）；i3 TWO 连接（203200-S）；i3 TWO 直连（203300-S）

K号: K222727 · 2023-06-02

申请人I3 Membrane GmbH
决定日期2023-06-02
产品代码NHV
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is the device name listed in this FDA 510(k) record. The listed applicant is I3 Membrane GmbH. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222727. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is I3 Membrane GmbH. The 510(k) number is K222727.

When did i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) receive FDA 510(k) clearance?

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222727.

Who is the listed applicant for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

The FDA 510(k) record lists I3 Membrane GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

The FDA product code for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is NHV.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：NHV）

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。

K261470QF10E.A.M Benelux B.VK191563FILTRAY 2G一次性水过滤器Aqua-ToolsK182164Ecolab POU 水过滤器喷嘴出口，Ecolab POU 水过滤器喷嘴出口，Ecolab POU 水过滤器花洒把手Ecolab, Inc.K173164Ecolab POU 水过滤器Ecolab, Inc.K163609Pall QPoint 水过滤器胶囊（淋浴），Pall QPoint 水过滤器胶囊（水龙头）Pall International SarlK161467HydraGuard 10 超滤器Nephros, Inc.

官方来源

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