FDA 510(k)

AK 98 腎透析機，U9000 超濾器，C705 扩充腔配件

K 號：K201809 · 2021-03-10

決定日期2021-03-10

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K201809. 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 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K201809.

When did AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory receive FDA 510(k) clearance?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory received FDA 510(k) clearance on 2021-03-10, under 510(k) number K201809.

Who is the listed applicant for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

The FDA 510(k) record lists Baxter Healthcare Corportation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

The FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is KDI.

其他以 Baxter Healthcare Corportation 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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