K251247

GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)

510(k) 号: K251247
器械名称: GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
申请人: Boston Scientific Neuromodulation Corporation CA · US
产品代码: GXD — Generator, Lesion, Radiofrequency
批准日期: 2025-08-07
受理日期: 2025-04-23
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Neurology

PDF下载 510(k) Summary本站存档 · 2.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K251247.pdf

FDA 官方记录： K251247

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。