K252793

ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

510(k) 号: K252793
器械名称: ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
申请人: Jiangsu Jiyuan Medical Technology Co., Ltd. CN
产品代码: HIH — Hysteroscope (And Accessories)
批准日期: 2025-12-18
受理日期: 2025-08-29
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Obstetrics/Gynecology

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： K252793.pdf

FDA 官方记录： K252793

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。