POS
- 产品代码
- POS
- 器械名称
- Physiological Signal Based Seizure Monitoring System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.1580
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 10 件
FDA 分类定义
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.
该代码近三年的 510(k)（5 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K251506 | 2025-11-21 | Neuro Event Labs OY | Nelli (Version 7.11) | |
| K243199 | 2025-07-12 | Livassured BV | NightWatch+ US | |
| K250515 | 2025-06-19 | Empatica S.r.l. | EpiMonitor | |
| K243515 | 2025-03-07 | Epiwatch, Inc. | EpiWatch Monitoring System | |
| K232915 | 2024-02-15 | Empatica S.r.l. | EpiMonitor |
FDA 官方分类页： POS
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。