K233225

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

510(k) 号: K233225
器械名称: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
申请人: Schoelly Fiberoptic GmbH DE
产品代码: GCJ — Laparoscope, General & Plastic Surgery
批准日期: 2024-06-20
受理日期: 2023-09-28
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

也可从 FDA 官方下载： K233225.pdf

FDA 官方记录： K233225

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。