FDA 510(k)

FB-U 靜脈透析器

K 號：K160444 · 2017-02-08

決定日期2017-02-08

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

FB-U Hemodialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K160444. 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 FB-U Hemodialyzer?

FB-U Hemodialyzer is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Nipro Medical Corporation. The 510(k) number is K160444.

When did FB-U Hemodialyzer receive FDA 510(k) clearance?

FB-U Hemodialyzer received FDA 510(k) clearance on 2017-02-08, under 510(k) number K160444.

Who is the listed applicant for FB-U Hemodialyzer?

FDA 510(k) 記錄中將 Nipro 医療公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for FB-U Hemodialyzer?

The FDA product code for FB-U Hemodialyzer is KDI.

其他以 Nipro Medical Corporation 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, LLC K252377NxStage System One 配 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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