OMB
- 产品代码
- OMB
- 器械名称
- Automatic Event Detection Software For Full-Montage Electroencephalograph
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.1400
- 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)
- 42 件
FDA 分类定义
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
该代码近三年的 510(k)（11 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260998 | 2026-06-24 | Ceribell, Inc. | Ceribell Neurology Review Software | FDA |
| K252070 | 2025-11-21 | Ceribell, Inc. | Ceribell Infant Seizure Detection Software | |
| K252160 | 2025-10-31 | Persyst Development, LLC | Persyst 15 EEG Review and Analysis Software (Persyst | — |
| K243743 | 2025-04-09 | Holberg Eeg AS | autoSCORE (V 2.0.0) | |
| K241589 | 2025-04-09 | Ceribell, Inc. | Ceribell Seizure Detection Software | FDA |
| K242446 | 2025-01-22 | Persyst Development Corporation | Persyst 15 EEG Review and Analysis Software (Persyst | — |
| K241390 | 2024-11-26 | LVIS Corporation | NeuroMatch | |
| K240408 | 2024-10-17 | Epitel, Inc. | REMI-AI Rapid Detection Module (REMI-AI RDM) | |
| K240993 | 2024-09-27 | Ait Austrian Institute of Technology G | encevis (2.1) | |
| K231068 | 2024-01-07 | Holberg Eeg AS | autoSCORE | |
| K231779 | 2024-01-03 | Epitel, Inc. | REMI AI Discrete Detection Module |
FDA 官方分类页： OMB
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。