K242291
- 510(k) 号
- K242291
- 器械名称
- SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
- 申请人
- Sol-Millennium Medical, Inc. IL · US
- 产品代码
- QNQ — Low Dead Space Piston Syringe
- 批准日期
- 2024-11-20
- 受理日期
- 2024-08-02
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General Hospital
FDA 官方记录: K242291
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。