QFB

Isocapnic Ventilation Device

产品代码

QFB

器械名称

Isocapnic Ventilation Device

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.5480

FDA 专业组

General Hospital

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).

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）。