SAK
- 产品代码
- SAK
- 器械名称
- Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.6316
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.
该代码近三年的 510(k)（2 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K250680 | 2026-04-30 | Bayesian Health, Inc. | Bayesian Health Sepsis Flagging Device | |
| DEN230036 | 2024-04-02 | Prenosis, Inc. | Sepsis ImmunoScore | — |
FDA 官方分类页： SAK
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。