5008X 血液透析系統
K 號：K231534 · 2024-02-02
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器材摘要
5008X Hemodialysis System is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K231534. 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 5008X Hemodialysis System?
5008X Hemodialysis System is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Fresenius Medical Care. The 510(k) number is K231534.
When did 5008X Hemodialysis System receive FDA 510(k) clearance?
5008X Hemodialysis System received FDA 510(k) clearance on 2024-02-02, under 510(k) number K231534.
Who is the listed applicant for 5008X Hemodialysis System?
The FDA 510(k) record lists Fresenius Medical Care as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 5008X Hemodialysis System?
The FDA product code for 5008X Hemodialysis System is KDI.
相關臨床試驗
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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
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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