K250152
- 510(k) 号
- K250152
- 器械名称
- eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
- 申请人
- Shenzhen TPH Technology Co., Ltd. CN
- 产品代码
- HGX — Pump, Breast, Powered
- 批准日期
- 2025-04-02
- 受理日期
- 2025-01-21
- 决定
- Substantially Equivalent
- 审查途径
- Special
- 咨询委员会
- Obstetrics/Gynecology
FDA 官方记录: K250152
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。