QNV
- 产品代码
- QNV
- 器械名称
- Adjunctive Hemodynamic Indicator With Decision Point
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.2220
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 3 件
FDA 分类定义
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
FDA 官方分类页: QNV
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。