NZJ

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

产品代码: NZJ
器械名称: Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 880.6260
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): 2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.

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： NZJ

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。