K240480

IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

510(k) 号
K240480
器械名称
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
申请人
Varian Medical Systems, Inc. CA · US
产品代码
NEY — System, Ablation, Microwave And Accessories
批准日期
2024-07-19
受理日期
2024-02-20
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
General, Plastic Surgery
PDF下载 510(k) Summary本站存档 · 2.6 MB · FDA 公有领域文件

也可从 FDA 官方下载: K240480.pdf

FDA 官方记录: K240480
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。