NVO

Spacer, Direct Patient Interface

产品代码

NVO

器械名称

Spacer, Direct Patient Interface

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.5630

FDA 专业组

Anesthesiology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

2 件

FDA 分类定义

Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.

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）。