K243629

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

510(k) 号: K243629
器械名称: Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
申请人: Shenzhen Root Innovation Technology Co., , Ltd. CN
产品代码: HGX — Pump, Breast, Powered
批准日期: 2024-12-20
受理日期: 2024-11-25
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Obstetrics/Gynecology

该申请提交的是 510(k) Statement 而非 Summary，FDA 不公开摘要全文；可向申请人索取。

FDA 官方记录： K243629

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。