QYW
- 产品代码
- QYW
- 器械名称
- Hospital Cardiac Telemetry
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.1025
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属生命支持/维持器械
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and recording of cardiac electrical activity, automated detection of life-threatening arrhythmias or other relevant conditions, and/or alarm generation. Devices may allow remote access and display of electrocardiograms acquired. Devices are intended for patients who require continuous monitoring in hospitals or healthcare facilities, with onsite medical review by qualified personnel at the central monitoring/analysis station followed by immediate notification of onsite qualified medical responders. Devices may be used for patients at elevated risk of serious cardiovascular events that would require prompt intervention. Devices are intended for prescription use only.