FDA 510(k)

SC+ 血液透析設備，SC+ 過濾濃縮液芯片，SC+ 血液試管組

K 號：K222067 · 2022-11-10

決定日期2022-11-10

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K222067. 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 SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K222067.

When did SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set receive FDA 510(k) clearance?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222067.

Who is the listed applicant for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA 510(k) record lists Quanta Dialysis Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is KDI.

其他以 Quanta Dialysis Technologies, Ltd. 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。

K242269SC+ 血液透析設備（SC-14269）；透析濾液芯片（SC-14656）；血液採血管套組（SC-14651）K210661SC+ 血液透析機，SC+ 過濾濃縮液針筒，SC+ 血管管路套件 K193670SC+ 血液透析機、SC+ 透析液匣、SC+ 血液管路組

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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