OMB · Automatic Event Detection Software For Full-Montage Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OMB |
|---|---|
| Device Name | Automatic Event Detection Software For Full-Montage Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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 | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | Nov 21, 2025 | SESE |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | Oct 31, 2025 | SESE |
| K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | Apr 9, 2025 | SESE |
| K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | Apr 9, 2025 | SESE |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | Jan 22, 2025 | SESE |
| K241390 | NeuroMatch | LVIS Corporation | Nov 26, 2024 | SESE |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | Oct 17, 2024 | SESE |
| K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | Sep 27, 2024 | SESE |
| K231068 | autoSCORE | Holberg Eeg AS | Jan 7, 2024 | SESE |
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | Jan 3, 2024 | SESE |
| K222450 | LVIS NeuroMatch | LVIS Corporation | Jun 9, 2023 | SESE |
| K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | May 23, 2023 | SESE |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | Dec 30, 2022 | SESE |
| K211452 | Encevis | Austrian Institute of Technology GmbH | Dec 2, 2021 | SESE |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | May 18, 2020 | SESE |
| K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | Sep 11, 2019 | SESE |
| K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | Nov 29, 2018 | SESE |
| K171720 | encevis | Ait Austrian Institute of Technology GmbH | Apr 19, 2018 | SESE |
| K180421 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Mar 14, 2018 | SESE |
| K171184 | 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
