QNY
- 产品代码
- QNY
- 器械名称
- Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
- 管理类别
- 第 N 类（Not Classified）
- FDA 专业组
- Unknown
- 上市路径
- EUA - Emergency Use Authorization
FDA 分类定义
To be used by healthcare professionals (HCP) in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment with drugs that can prolong QT intervals and may cause life threatening arrhythmias. Device used during declared public health emergency.
FDA 官方分类页： QNY
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。