OMB
- Product code
- OMB
- Device name
- Automatic Event Detection Software For Full-Montage Electroencephalograph
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1400
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 42
FDA classification definition
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
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 |
Official FDA classification page: OMB
Classification and pathway per current FDA publications. Data from openFDA (CC0).