PMJ
- 产品代码
- PMJ
- 器械名称
- Cpr Aid Feedback Device (No Software)
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.5210
- FDA 专业组
- Cardiovascular
- 上市路径
- 豁免 510(k)(仍须遵守通用控制与注册列名)
FDA 分类定义
Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines
FDA 官方分类页: PMJ
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。