FDA 510(k) Applications for Medical Device Product Code "OMB"
(Automatic Event Detection Software For Full-Montage Electroencephalograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K171720 | AIT Austrian Institute of Technology GmbH | encevis | 04/19/2018 |
| K240993 | AIT Austrian Institute of Technology GmbH | encevis (2.1) | 09/27/2024 |
| K211452 | Austrian Institute of Technology GmbH | Encevis | 12/02/2021 |
| K140552 | CADWELL | CADWELL SPIKE AND SEIZURE DETECTOR | 07/23/2014 |
| K191301 | Ceribell, Inc. | Ceribell Pocket EEG Device | 09/11/2019 |
| K241589 | Ceribell, Inc. | Ceribell Seizure Detection Software | 04/09/2025 |
| K223504 | Ceribell, Inc. | Ceribell Status Epilepticus Monitor | 05/23/2023 |
| K240408 | Epitel, Inc | REMI-AI Rapid Detection Module (REMI-AI RDM) | 10/17/2024 |
| K231779 | Epitel, Inc. | REMI AI Discrete Detection Module | 01/03/2024 |
| K010085 | EXCEL TECH. LTD. | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) | 03/15/2001 |
| K002332 | EXCEL TECH. LTD. | EEG SPIKE AND EVENT DETECTOR MODULE | 10/06/2000 |
| K042223 | EXCEL TECH. LTD. | XLTEK CONNEX IP HEADBOX, MODEL 1054 | 09/16/2004 |
| K120260 | EXCEL-TECH LTD. (XLTEK) | ICTA | 06/29/2012 |
| K231068 | Holberg EEG AS | autoSCORE | 01/07/2024 |
| K243743 | Holberg EEG AS | autoSCORE (V 2.0.0) | 04/09/2025 |
| K222450 | LVIS Corporation | LVIS NeuroMatch | 06/09/2023 |
| K241390 | LVIS Corporation | NeuroMatch | 11/26/2024 |
| K200878 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Natus NeuroWorks | 05/18/2020 |
| K180421 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Natus NeuroWorks | 03/14/2018 |
| K090019 | NATUS MEDICAL, INC. | NATUS NEUROWORKS, MODEL 104196 | 02/22/2010 |
| K955787 | NEW ENGLAND MEDICAL INSTRUMENTS, INC. | DIGITRACE HOME VIDEO SYSTEM | 02/09/1996 |
| K150688 | OPTIMA NEUROSCIENCE, INC. | IdentEvent | 11/05/2015 |
| K092039 | OPTIMA NEUROSCIENCE, INC. | IDENTEVENT, VERSION 1.0G | 10/16/2009 |
| K132306 | PERSYST DEVELOPMENT CORP. | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE | 11/21/2013 |
| K011397 | PERSYST DEVELOPMENT CORP. | PERSYST REVEAL | 08/03/2001 |
| K133793 | PERSYST DEVELOPMENT CORPORATION | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | 05/19/2014 |
| K151929 | PERSYST DEVELOPMENT CORPORATION | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | 08/12/2015 |
| K182181 | Persyst Development Corporation | Persyst 14 EEG Review and Analysis Software | 11/29/2018 |
| K222002 | Persyst Development Corporation | Persyst 15 EEG Review and Analysis Software | 12/30/2022 |
| K242446 | Persyst Development Corporation | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | 01/22/2025 |
| K171184 | Persyst Development Corporation | Persyst Mobile App | 09/21/2017 |
| K141883 | PICOFEMTO LLC | CLINISCANSM EEG | 05/15/2015 |
| K960273 | STELLATE SYSTEMS | HARMONIE SENSA | 04/04/1996 |
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