K234130
- 510(k) 号
- K234130
- 器械名称
- Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
- 申请人
- Ge Medical Systems Information Technologies, Inc. WI · US
- 产品代码
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- 批准日期
- 2024-03-20
- 受理日期
- 2023-12-28
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Cardiovascular
510(k) Summary（FDA 官方 PDF）： K234130.pdf
FDA 官方记录： K234130
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。