QTB

Nitric Oxide Generator And Delivery System

产品代码: QTB
器械名称: Nitric Oxide Generator And Delivery System
管理类别: 第 3 类（Class III）
FDA 专业组: Unknown
上市路径: 需 PMA 上市前批准
标记: 属生命支持/维持器械

FDA 分类定义

The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2).

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： QTB

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。