QGH

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

产品代码

QGH

器械名称

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 882.5940

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)

9 件

FDA 分类定义

Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

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）。