说明与适用边界
此页按所列地区、版本归档。标签内容可能更新，具体产品请核对原始来源；本站关联表示阅读线索，不表示药品与器械可兼容或可替换。
监管定义 / Regulatory definition
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
监管信息 / Regulatory information
FDA product code: PMJ
Device class: 2
Regulation: 870.5210
Specialty: Cardiovascular
Implant flag: N
Life sustaining/supporting flag: N
使用说明核对
该条目描述监管产品类别，不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书，核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。
来源、版本与许可
- 资料类型
- FDA 器械监管分类（非厂家操作说明书）
- 版本
- 2026-10-08
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.