NZK

Stimulator, Low Electric Field, Tumor Treatment

产品代码

NZK

器械名称

Stimulator, Low Electric Field, Tumor Treatment

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

标记

属生命支持/维持器械

FDA 分类定义

Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.

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）。