K231659

MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)

510(k) 号: K231659
器械名称: MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)
申请人: Medisono FL · US
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2024-02-15
受理日期: 2023-06-07
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 · 0.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K231659.pdf

FDA 官方记录： K231659

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。