OMB — Automatic Event Detection Software For Full-Montage Electroencephalograph Class II
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 |
|---|---|---|---|
| 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 |
| K171184 | persyst development corporation | Persyst Mobile App | September 21, 2017 |