QOV

Critical Care Ventilator

产品代码: QOV
器械名称: Critical Care Ventilator
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

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： QOV

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。