PMK
- 产品代码
- PMK
- 器械名称
- Cpr Aid Device Without Feedback
- 管理类别
- 第 1 类（Class I）
- 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）
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.
FDA 官方分类页： PMK
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。