QYF

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

产品代码: QYF
器械名称: Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 870.1130
FDA 专业组: Cardiovascular
上市路径: 需提交 510(k) 上市前通告

FDA 分类定义

The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring.

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： QYF

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。