NSA

Over-The-Counter Automated External Defibrillator

产品代码

NSA

器械名称

Over-The-Counter Automated External Defibrillator

管理类别

第 3 类（Class III）

21 CFR 条款

21 CFR 870.5310

FDA 专业组

Cardiovascular

上市路径

需 PMA 上市前批准

标记

属生命支持/维持器械

该代码近三年的 510(k)

1 件

FDA 分类定义

Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.

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）。