K234041
- 510(k) 号
- K234041
- 器械名称
- Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
- 申请人
- Andon Health Co, Ltd. CN
- 产品代码
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- 批准日期
- 2024-04-22
- 受理日期
- 2023-12-21
- 决定
- Substantially Equivalent
- 审查途径
- Abbreviated
- 咨询委员会
- Cardiovascular
FDA 官方记录: K234041
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。