Product code OMB
- Device name
- Automatic Event Detection Software For Full-Montage Electroencephalograph
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | 2025-10-31 |
| K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | 2025-04-09 |
| K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | 2025-04-09 |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | 2025-01-22 |
| K241390 | NeuroMatch | LVIS Corporation | 2024-11-26 |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024-10-17 |
| K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024-09-27 |
| K231068 | autoSCORE | Holberg Eeg AS | 2024-01-07 |
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | 2024-01-03 |
| K222450 | LVIS NeuroMatch | LVIS Corporation | 2023-06-09 |
| K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023-05-23 |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | 2022-12-30 |
| K211452 | Encevis | Austrian Institute of Technology GmbH | 2021-12-02 |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020-05-18 |
| K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019-09-11 |
| K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | 2018-11-29 |
| K171720 | encevis | Ait Austrian Institute of Technology GmbH | 2018-04-19 |
| K180421 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-14 |
| K171184 | Persyst Mobile App | Persyst Development Corporation | 2017-09-21 |
| K150688 | IdentEvent | Optima Neuroscience, Inc. | 2015-11-05 |
| K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corporation | 2015-08-12 |
| K141883 | CLINISCANSM EEG | Picofemto, LLC | 2015-05-15 |
| K140552 | CADWELL SPIKE AND SEIZURE DETECTOR | Cadwell | 2014-07-23 |
| K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corporation | 2014-05-19 |
| K132306 | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corp. | 2013-11-21 |
| K120260 | ICTA | Excel-Tech Ltd. (Xltek) | 2012-06-29 |
| K090019 | NATUS NEUROWORKS, MODEL 104196 | Natus Medical, Inc. | 2010-02-22 |
| K092039 | IDENTEVENT, VERSION 1.0G | Optima Neuroscience, Inc. | 2009-10-16 |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | Excel Tech. , Ltd. | 2004-09-16 |
| K011397 | PERSYST REVEAL | Persyst Development Corp. | 2001-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850056774017 | NeuroMatch | LVIS CORPORATION | 2026-05-12 |
| 05060941990018 | Autoscore | Holberg Eeg AS | 2026-01-28 |
| 09120109830269 | encevis | AIT Austrian Institute of Technology GmbH | 2025-08-05 |
| 00850056774000 | NeuroMatch | LVIS CORPORATION | 2025-04-04 |
| 00860005388189 | REMI Vigilenz | Epitel, Inc. | 2024-03-11 |
| 00869732000166 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corp | 2023-07-24 |
| 09120109830122 | encevis | AIT Austrian Institute of Technology GmbH | 2022-07-15 |
| 00382830058506 | Natus | XLTEK | 2021-10-07 |
| 00382830007443 | Natus | XLTEK | 2021-10-07 |
| 00851420007052 | Pocket EEG Device | CERIBELL, INC. | 2021-08-02 |
| 00382830058209 | Natus | XLTEK | 2021-04-20 |
| 00382830058216 | Natus | XLTEK | 2021-04-20 |
| 00382830058575 | Natus | XLTEK | 2021-04-20 |
| 09120109830078 | encevis | AIT Austrian Institute of Technology GmbH | 2021-01-11 |
| 00382830010924 | Natus | XLTEK | 2019-11-27 |
| 00382830008020 | Natus | XLTEK | 2019-11-27 |
| 00869732000135 | Persyst Mobile App | Persyst Development Corp | 2019-04-08 |
| 00869732000128 | Persyst 14 Review and Analysis Software | Persyst Development Corp | 2019-04-08 |
| 00869732000142 | Persyst Mobile App | Persyst Development Corp | 2019-04-08 |
| 00851420007045 | Pocket EEG Device, EEG Recording Viewer Software | CERIBELL, INC. | 2018-03-28 |
| 00382830002820 | Natus | XLTEK | 2016-09-13 |
| 00382830002745 | Natus | XLTEK | 2016-09-13 |
| 00382830002677 | Natus | XLTEK | 2016-09-13 |
| 00382830002554 | Natus | XLTEK | 2016-09-13 |
| 00382830002547 | Natus | XLTEK | 2016-09-13 |
| 00382830002523 | Natus | XLTEK | 2016-09-13 |
| 00382830002516 | Natus | XLTEK | 2016-09-13 |
| 00382830002493 | Natus | XLTEK | 2016-09-13 |
| 00869732000111 | Persyst 13 EEG Review and Analysis Software | Persyst Development Corp | 2016-09-01 |
| 00869732000104 | Persyst 12 EEG Review and Analysis Software | Persyst Development Corp | 2016-09-01 |