FDA 510(k)

NxStage Cartridge Express with Speedswap

K号: K183158 · 2019-08-09

决定日期2019-08-09

产品代码KDI

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决定实质等同

器械摘要

NxStage Cartridge Express with Speedswap is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K183158. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NxStage Cartridge Express with Speedswap?

NxStage Cartridge Express with Speedswap is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K183158.

When did NxStage Cartridge Express with Speedswap receive FDA 510(k) clearance?

NxStage Cartridge Express with Speedswap received FDA 510(k) clearance on 2019-08-09, under 510(k) number K183158.

Who is the listed applicant for NxStage Cartridge Express with Speedswap?

The FDA 510(k) record lists Nxstage Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NxStage Cartridge Express with Speedswap?

The FDA product code for NxStage Cartridge Express with Speedswap is KDI.

列明Nxstage Medical, 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。

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow Solution K230632VersiHD 配合 GuideMe 软件 K181991NxStage Connected Health System K171331NxStage System One K170469NxStage System One Plus

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相关器械（代码：KDI）

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。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130（F00013123）；multiFlux 160（F00013124）Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo血液透析系统（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX CorAL 40；FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

官方来源

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