OZR

Intraoral Pressure Gradient Device

产品代码

OZR

器械名称

Intraoral Pressure Gradient Device

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 872.5570

FDA 专业组

Dental

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

6 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward. It is intended to be used while a patient is sleeping to treat obstructive sleep apnea.

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）。