K233913

Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

510(k) 号: K233913
器械名称: Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
申请人: Aoj Health Technology Co., Ltd. CN
产品代码: HGX — Pump, Breast, Powered
批准日期: 2024-05-14
受理日期: 2023-12-12
决定: Substantially Equivalent
审查途径: Traditional
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： K233913

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。