ONZ

Mechanical Ventilator

产品代码

ONZ

器械名称

Mechanical Ventilator

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.5895

FDA 专业组

Anesthesiology

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

6 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,

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）。