K243178

Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di

510(k) 号: K243178
器械名称: Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di
申请人: Shantou Institute of Ultrasonic Instruments Co., Ltd. CN
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2025-03-31
受理日期: 2024-09-30
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 · 2.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243178.pdf

FDA 官方记录： K243178

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。