8 devices · 7 companies · 2018 to 2025
Product code OMB: Automatic Event Detection Software For Full-Montage Electroencephalograph
8 devices under product code OMB, 2018 to 2025, from 7 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 here), the regulation, and MAUDE report counts by product code.
Automatic Event Detection Software For Full-Montage Electroencephalograph. 21 CFR 882.1400, Class II. 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 MAUDE held 36 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| autoSCOREK243743 · 510(k) | Holberg EEG AS | Neurology | database entry | |
| NeuroMatchK241390 · 510(k) | LVIS Corporation | Neurology | database entry | |
| REMI-AI Rapid Detection ModuleK240408 · 510(k) | Epitel, Inc | Neurology | database entry | |
| encevisK240993 · 510(k) | AIT Austrian Institute of Technology GmbH | Neurology | database entry | |
| autoSCOREK231068 · 510(k) | Holberg EEG AS | Neurology | database entry | |
| REMI AI Discrete Detection ModuleK231779 · 510(k) | Epitel, Inc. | Neurology | database entry | |
| Ceribell Status Epilepticus MonitorK223504 · 510(k) | Ceribell, Inc. | Neurology | database entry | |
| Persyst 14 EEG Review and Analysis SoftwareK182181 · 510(k) | Persyst Development Corporation | Neurology | database entry |
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