K252250

Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

510(k) 号: K252250
器械名称: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
申请人: Shanghai Draeger Medical Instrument Co., Ltd. CN
产品代码: MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
批准日期: 2026-04-10
受理日期: 2025-07-17
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Cardiovascular

PDF下载 510(k) Summary本站存档 · 2.4 MB · FDA 公有领域文件

也可从 FDA 官方下载： K252250.pdf

FDA 官方记录： K252250

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。