K233942

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

510(k) 号: K233942
器械名称: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
申请人: Pentax of America, Inc. NJ · US
产品代码: FDT — Duodenoscope And Accessories, Flexible/Rigid
批准日期: 2024-08-01
受理日期: 2023-12-14
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 1.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K233942.pdf

FDA 官方记录： K233942

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。