K252247

Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

510(k) 号: K252247
器械名称: Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
申请人: Olympus Medical Systems Corporation JP
产品代码: FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
批准日期: 2025-10-16
受理日期: 2025-07-18
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 · 0.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K252247.pdf

FDA 官方记录： K252247

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。