HydraGuard 10 超滤器
K号: K161467 · 2016-12-22
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决定日期2016-12-22
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
HydraGuard 10 UltraFilter is the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K161467. 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 HydraGuard 10 UltraFilter?
HydraGuard 10 UltraFilter is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Nephros, Inc.. The 510(k) number is K161467.
When did HydraGuard 10 UltraFilter receive FDA 510(k) clearance?
HydraGuard 10 UltraFilter received FDA 510(k) clearance on 2016-12-22, under 510(k) number K161467.
Who is the listed applicant for HydraGuard 10 UltraFilter?
The FDA 510(k) record lists Nephros, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HydraGuard 10 UltraFilter?
The FDA product code for HydraGuard 10 UltraFilter is NHV.
相关临床试验
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列明Nephros, Inc.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。
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.VK222727i3 ONE（203100-S）；i3 TWO 连接（203200-S）；i3 TWO 直连（203300-S）I3 Membrane GmbHK191563FILTRAY 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 Sarl
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。
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