K251637

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

510(k) 号: K251637
器械名称: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
申请人: Donnevie Medical Technology (Shanghai) Co. , Ltd. CN
产品代码: MQL — Media, Reproductive
批准日期: 2025-08-27
受理日期: 2025-05-29
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Obstetrics/Gynecology

510(k) Summary（FDA 官方 PDF）： K251637.pdf

FDA 官方记录： K251637

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。