FDA 510(k)

Optiflux透析器

K 號：K162488 · 2017-04-06

決定日期2017-04-06

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

Optiflux dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162488. 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 dialyzer?

Optiflux dialyzer is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K162488.

When did Optiflux dialyzer receive FDA 510(k) clearance?

Optiflux dialyzer received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162488.

Who is the listed applicant for Optiflux dialyzer?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optiflux dialyzer?

The FDA product code for Optiflux dialyzer is KDI.

其他以 Fresenius Medical Care North America 為申請人之記錄

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K252181AquaA

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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