Optiflux Enexa F500 腎透析器
K 號：K192928 · 2020-07-09
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器材摘要
Optiflux Enexa F500 Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K192928. 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 Optiflux Enexa F500 Dialyzer?
Optiflux Enexa F500 Dialyzer is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. The 510(k) number is K192928.
When did Optiflux Enexa F500 Dialyzer receive FDA 510(k) clearance?
Optiflux Enexa F500 Dialyzer received FDA 510(k) clearance on 2020-07-09, under 510(k) number K192928.
Who is the listed applicant for Optiflux Enexa F500 Dialyzer?
The FDA 510(k) record lists Fresenius Medical Care Reanal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optiflux Enexa F500 Dialyzer?
The FDA product code for Optiflux Enexa F500 Dialyzer 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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