K242176

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

510(k) 号: K242176
器械名称: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
申请人: NIKKISO CO., LTD. JP
产品代码: KOC — Accessories, Blood Circuit, Hemodialysis
批准日期: 2025-05-15
受理日期: 2024-07-24
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 1.1 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242176.pdf

FDA 官方记录： K242176

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。