QMZ

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

产品代码

QMZ

器械名称

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 882.5705

FDA 专业组

Neurology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post traumatic stress disorder (PTSD).

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）。