K241934

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

510(k) 号: K241934
器械名称: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
申请人: Anx Robotica Corp TX · US
产品代码: QKZ — Magnetically Maneuvered Capsule Endoscopy System
批准日期: 2024-07-31
受理日期: 2024-07-02
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 1.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K241934.pdf

FDA 官方记录： K241934

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。