PPW
- 产品代码
- PPW
- 器械名称
- Adjunctive Cardiovascular Status Indicator
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.2200
- 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)
- 8 件
FDA 分类定义
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This 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)(3 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K254066 | 2026-04-03 | Etiometry, Inc. | Etiometry Platform | |
| K252204 | 2025-12-16 | Prolaio, Inc. | prolaio eVO2peak Module (Version 1.0) | |
| K241479 | 2025-02-12 | Etiometry, Inc. | Etiometry Platform (DAV 5.4 RAE 9.2) | FDA |
FDA 官方分类页: PPW
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。