QMS
- 产品代码
- QMS
- 器械名称
- Adjunctive Open Loop Fluid Therapy Recommender
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.5600
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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 |
|---|---|---|---|---|
| K233984 | 2024-08-02 | Edwards Lifesciences, LLC | Acumen Assisted Fluid Management (AFM) Software Feat |
FDA 官方分类页: QMS
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。