K232294

HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)

510(k) 号: K232294
器械名称: HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
申请人: Edwards Lifesciences, LLC CA · US
产品代码: DQK — Computer, Diagnostic, Programmable
批准日期: 2023-10-31
受理日期: 2023-08-01
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 · 2.2 MB · FDA 公有领域文件

也可从 FDA 官方下载： K232294.pdf

FDA 官方记录： K232294

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。