K252066

inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)

510(k) 号: K252066
器械名称: inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
申请人: Vincent Healthcare Products Limited HK
产品代码: BZE — Heater, Breathing System W/Wo Controller (Not Humidi
批准日期: 2026-06-18
受理日期: 2025-07-01
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Anesthesiology

PDF下载 510(k) Summary本站存档 · 0.9 MB · FDA 公有领域文件

也可从 FDA 官方下载： K252066.pdf

FDA 官方记录： K252066

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。