K250470

Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

510(k) 号: K250470
器械名称: Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
申请人: Shenzhen AOJ Medical Technology Co., Ltd. CN
产品代码: FLL — Continuous Measurement Thermometer
批准日期: 2025-06-23
受理日期: 2025-02-18
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

也可从 FDA 官方下载： K250470.pdf

FDA 官方记录： K250470

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。