K243652

Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)

510(k) 号: K243652
器械名称: Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)
申请人: Cardinalhealth IL · US
产品代码: PNR — Enteral Syringes With Enteral Specific Connectors
批准日期: 2024-12-19
受理日期: 2024-11-26
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Gastroenterology, Urology

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： K243652

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。