FDA 510(k)

CAREline 無氣動力血液透析血管路設備套組

K 號：K172238 · 2017-12-14

申請人Fresenius Medical Care Renal Therapies Group, LLC

決定日期2017-12-14

產品代碼KOC

諮詢委員會GU

決定相當於

器材摘要

CAREline Airless Hemodialysis Blood Tubing Sets is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K172238. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAREline Airless Hemodialysis Blood Tubing Sets?

CAREline Airless Hemodialysis Blood Tubing Sets is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K172238.

When did CAREline Airless Hemodialysis Blood Tubing Sets receive FDA 510(k) clearance?

CAREline Airless Hemodialysis Blood Tubing Sets received FDA 510(k) clearance on 2017-12-14, under 510(k) number K172238.

Who is the listed applicant for CAREline Airless Hemodialysis Blood Tubing Sets?

FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for CAREline Airless Hemodialysis Blood Tubing Sets?

The FDA product code for CAREline Airless Hemodialysis Blood Tubing Sets is KOC.

其他以 Fresenius Medical Care Renal Therapies Group, LLC 為申請人之記錄

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相關器械（代碼：KOC）

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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官方來源

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