K243702

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

510(k) 号
K243702
器械名称
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 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
2025-02-12
受理日期
2024-11-29
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 · 0.5 MB · FDA 公有领域文件

也可从 FDA 官方下载: K243702.pdf

FDA 官方记录: K243702
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。