OMB — Automatic Event Detection Software For Full-Montage Electroencephalograph Class II
FDA product code OMB covers "Automatic Event Detection Software For Full-Montage Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OMB
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260998 | ceribell | Ceribell Neurology Review Software | June 24, 2026 |
| K252070 | ceribell | Ceribell Infant Seizure Detection Software | November 21, 2025 |
| K252160 | persyst development | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | October 31, 2025 |
| K243743 | holberg eeg | autoSCORE (V 2.0.0) | April 9, 2025 |
| K241589 | ceribell | Ceribell Seizure Detection Software | April 9, 2025 |
| K242446 | persyst development corporation | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | January 22, 2025 |
| K241390 | lvis corporation | NeuroMatch | November 26, 2024 |
| K240408 | epitel | REMI-AI Rapid Detection Module (REMI-AI RDM) | October 17, 2024 |
| K240993 | ait austrian institute of technology | encevis (2.1) | September 27, 2024 |
| K231068 | holberg eeg | autoSCORE | January 7, 2024 |
| K231779 | epitel | REMI AI Discrete Detection Module | January 3, 2024 |
| K222450 | lvis corporation | LVIS NeuroMatch | June 9, 2023 |
| K223504 | ceribell | Ceribell Status Epilepticus Monitor | May 23, 2023 |
| K222002 | persyst development corporation | Persyst 15 EEG Review and Analysis Software | December 30, 2022 |
| K211452 | austrian institute of technology | Encevis | December 2, 2021 |
| K200878 | natus medical incorporated dba excel-tech ltd. (xltek) | Natus NeuroWorks | May 18, 2020 |
| K191301 | ceribell | Ceribell Pocket EEG Device | September 11, 2019 |
| K182181 | persyst development corporation | Persyst 14 EEG Review and Analysis Software | November 29, 2018 |
| K171720 | ait austrian institute of technology | encevis | April 19, 2018 |
| K180421 | natus medical incorporated dba excel-tech ltd. (xltek) | Natus NeuroWorks | March 14, 2018 |