K242511

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

510(k) 号: K242511
器械名称: V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
申请人: Samsung Medison Co., Ltd. KR
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2024-12-10
受理日期: 2024-08-23
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Radiology

PDF下载 510(k) Summary本站存档 · 0.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242511.pdf

FDA 官方记录： K242511

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。