SAR
- 产品代码
- SAR
- 器械名称
- Adjunctive Hemodynamic Indicator With Decision Point For Military Use
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.2220
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military.
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K233249 | 2024-04-05 | The Surgeon General, Department of the | APPRAISE-HRI |
FDA 官方分类页: SAR
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。