HDF輔助模組、HDF輸液組及替換過濾器
K 號：K210575 · 2022-05-13
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器材摘要
HDF Assist Mudule, HDF Infusion Set and Substitution Filter is the device name listed in this FDA 510(k) record. The listed applicant is Nephros. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210575. 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 HDF Assist Mudule, HDF Infusion Set and Substitution Filter?
HDF Assist Mudule, HDF Infusion Set and Substitution Filter is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Nephros. The 510(k) number is K210575.
When did HDF Assist Mudule, HDF Infusion Set and Substitution Filter receive FDA 510(k) clearance?
HDF Assist Mudule, HDF Infusion Set and Substitution Filter received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210575.
Who is the listed applicant for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?
The FDA 510(k) record lists Nephros as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?
The FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter 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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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