NPB
- 产品代码
- NPB
- 器械名称
- System, Monitoring, For Progress Of Labor
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 884.2800
- FDA 专业组
- Ophthalmic
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 4 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.
FDA 官方分类页: NPB
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。