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FDA 510(k)

NxStage Cartridge Express 配合 Speedswap

K 號：K183158 · 2019-08-09

申請人Nxstage Medical, Inc.
決定日期2019-08-09
產品代碼KDI
諮詢委員會GU
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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其他以 Nxstage Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：KDI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One 配 NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123)；multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo血液透析系統（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX珊瑚40；FX珊瑚50Fresenius Medical Care Renal Therapies Group, LLC

官方來源

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