Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OMB — Automatic Event Detection Software For Full-Montage Electroencephalograph # OMB · Automatic Event Detection Software For Full-Montage Electroencephalograph _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB ## Overview - **Product Code:** OMB - **Device Name:** Automatic Event Detection Software For Full-Montage Electroencephalograph - **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 41) Showing 20 most recent of 41 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252070](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K252070.md) | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | Nov 21, 2025 | SESE | | [K252160](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K252160.md) | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | Oct 31, 2025 | SESE | | [K243743](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K243743.md) | autoSCORE (V 2.0.0) | Holberg Eeg AS | Apr 9, 2025 | SESE | | [K241589](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K241589.md) | Ceribell Seizure Detection Software | Ceribell, Inc. | Apr 9, 2025 | SESE | | [K242446](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K242446.md) | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | Jan 22, 2025 | SESE | | [K241390](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K241390.md) | NeuroMatch | LVIS Corporation | Nov 26, 2024 | SESE | | [K240408](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K240408.md) | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | Oct 17, 2024 | SESE | | [K240993](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K240993.md) | encevis (2.1) | Ait Austrian Institute of Technology GmbH | Sep 27, 2024 | SESE | | [K231068](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K231068.md) | autoSCORE | Holberg Eeg AS | Jan 7, 2024 | SESE | | [K231779](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K231779.md) | REMI AI Discrete Detection Module | Epitel, Inc. | Jan 3, 2024 | SESE | | [K222450](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K222450.md) | LVIS NeuroMatch | LVIS Corporation | Jun 9, 2023 | SESE | | [K223504](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K223504.md) | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | May 23, 2023 | SESE | | [K222002](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K222002.md) | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | Dec 30, 2022 | SESE | | [K211452](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K211452.md) | Encevis | Austrian Institute of Technology GmbH | Dec 2, 2021 | SESE | | [K200878](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K200878.md) | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | May 18, 2020 | SESE | | [K191301](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K191301.md) | Ceribell Pocket EEG Device | Ceribell, Inc. | Sep 11, 2019 | SESE | | [K182181](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K182181.md) | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | Nov 29, 2018 | SESE | | [K171720](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K171720.md) | encevis | Ait Austrian Institute of Technology GmbH | Apr 19, 2018 | SESE | | [K180421](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K180421.md) | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Mar 14, 2018 | SESE | | [K171184](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K171184.md) | Persyst Mobile App | Persyst Development Corporation | Sep 21, 2017 | SESE | ## Top Applicants - Persyst Development Corporation — 6 clearances - Ceribell, Inc. — 4 clearances - Excel Tech. , Ltd. — 3 clearances - Ait Austrian Institute of Technology GmbH — 2 clearances - Epitel, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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