NHK

Resuscitator, Manual, Non Self-Inflating

产品代码

NHK

器械名称

Resuscitator, Manual, Non Self-Inflating

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.5905

FDA 专业组

Anesthesiology

上市路径

需提交 510(k) 上市前通告

标记

属生命支持/维持器械

该代码近三年的 510(k)

10 件

FDA 分类定义

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

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）。