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FDA 510(k)

SC+ 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）

K 號：K242269 · 2024-11-01

申請人Quanta Dialysis Technologies, Ltd.
決定日期2024-11-01
產品代碼ONW
諮詢委員會GU
決定相當於

器材摘要

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) 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 2024-11-01 under 510(k) number K242269. The device is classified under product code ONW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K242269.

When did SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) receive FDA 510(k) clearance?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242269.

Who is the listed applicant for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

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-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

The FDA product code for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is ONW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K222067SC+ 血液透析設備，SC+ 過濾濃縮液芯片，SC+ 血液試管組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

官方來源

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