QRS

Device For Sleep Apnea Testing Based On Mandibular Movement

产品代码

QRS

器械名称

Device For Sleep Apnea Testing Based On Mandibular Movement

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.2376

FDA 专业组

Ear, Nose, Throat

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

3 件

FDA 分类定义

A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2025-08-29。

其中 1 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。