Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation 882.1400
2510(k)s in 12 months (42 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OMB
| Company | 510(k)s | Recalls |
|---|---|---|
| Persyst Development Corp. | 9 | 0 |
| Ceribell, Inc. | 5 | 0 |
| Excel Tech. , Ltd. | 3 | 0 |
| Ait Austrian Institute of Technology GmbH | 2 | 0 |
| Epitel, Inc. | 2 | 0 |
| Holberg Eeg AS | 2 | 0 |
| LVIS Corporation | 2 | 0 |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2 | 0 |
| New England Medical Instruments, Inc. | 2 | 0 |
| Optima Neuroscience, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2026 | K260998 | Ceribell Neurology Review Software Ceribell, Inc. | OMB |
| Nov 21, 2025 | K252070 | Ceribell Infant Seizure Detection Software Ceribell, Inc. | OMB |
| Oct 31, 2025 | K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) Persyst Development, LLC | OMB |
| Apr 9, 2025 | K243743 | autoSCORE (V 2.0.0) Holberg Eeg AS, NO | OMB |
| Apr 9, 2025 | K241589 | Ceribell Seizure Detection Software Ceribell, Inc. | OMB |
| Jan 22, 2025 | K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) Persyst Development Corporation | OMB |
| Nov 26, 2024 | K241390 | NeuroMatch LVIS Corporation | OMB |
| Oct 17, 2024 | K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) Epitel, Inc. | OMB |
| Sep 27, 2024 | K240993 | encevis (2.1) Ait Austrian Institute of Technology GmbH, AT | OMB |
| Jan 7, 2024 | K231068 | autoSCORE Holberg Eeg AS, NO | OMB |
| Jan 3, 2024 | K231779 | REMI AI Discrete Detection Module Epitel, Inc. | OMB |
| Jun 9, 2023 | K222450 | LVIS NeuroMatch LVIS Corporation | OMB |
| May 23, 2023 | K223504 | Ceribell Status Epilepticus Monitor Ceribell, Inc. | OMB |
| Dec 30, 2022 | K222002 | Persyst 15 EEG Review and Analysis Software Persyst Development Corporation | OMB |
| Dec 2, 2021 | K211452 | Encevis Austrian Institute of Technology GmbH, AT | OMB |
| May 18, 2020 | K200878 | Natus NeuroWorks Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMB |
| Sep 11, 2019 | K191301 | Ceribell Pocket EEG Device Ceribell, Inc. | OMB |
| Nov 29, 2018 | K182181 | Persyst 14 EEG Review and Analysis Software Persyst Development Corporation | OMB |
| Apr 19, 2018 | K171720 | encevis Ait Austrian Institute of Technology GmbH, AT | OMB |
| Mar 14, 2018 | K180421 | Natus NeuroWorks Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMB |
| Sep 21, 2017 | K171184 | Persyst Mobile App Persyst Development Corporation | OMB |
| Nov 5, 2015 | K150688 | IdentEvent Optima Neuroscience, Inc. | OMB |
| Aug 12, 2015 | K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE Persyst Development Corporation | OMB |
| May 15, 2015 | K141883 | CLINISCANSM EEG Picofemto, LLC | OMB |
| Jul 23, 2014 | K140552 | CADWELL SPIKE AND SEIZURE DETECTOR Cadwell | OMB |
| May 19, 2014 | K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE Persyst Development Corporation | OMB |
| Nov 21, 2013 | K132306 | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE Persyst Development Corp. | OMB |
| Jun 29, 2012 | K120260 | ICTA Excel-Tech Ltd. (Xltek), CA | OMB |
| Feb 22, 2010 | K090019 | NATUS NEUROWORKS, MODEL 104196 Natus Medical, Inc., CA | OMB |
| Oct 16, 2009 | K092039 | IDENTEVENT, VERSION 1.0G Optima Neuroscience, Inc. | OMB |
| Sep 16, 2004 | K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 Excel Tech. , Ltd., CA | OMB |
| Aug 3, 2001 | K011397 | PERSYST REVEAL Persyst Development Corp. | OMB |
| Mar 15, 2001 | K010085 | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) Excel Tech. , Ltd., CA | OMB |
| Oct 6, 2000 | K002332 | EEG SPIKE AND EVENT DETECTOR MODULE Excel Tech. , Ltd., CA | OMB |
| Apr 4, 1996 | K960273 | HARMONIE SENSA Stellate Systems, CA | OMB |
| Feb 9, 1996 | K955787 | DIGITRACE HOME VIDEO SYSTEM New England Medical Instruments, Inc. | OMB |
| Aug 22, 1995 | K951594 | BIO-LOGIC AUTOMATIC EVENT ANALYSIS Bio-Logic Systems Corp. | OMB |
| May 15, 1995 | K950270 | NMI SOFTWARE Nicolet Biomedical, Inc. | OMB |
| May 4, 1995 | K944833 | DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM New England Medical Monitoring Co. | OMB |
| Apr 5, 1995 | K950117 | PERSYST SPIKE DETECTOR Persyst Consulting Services, Inc. | OMB |
| Dec 18, 1991 | K910771 | DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX New England Medical Instruments, Inc. | OMB |
| Apr 8, 1987 | K870450 | SZAC-16 SEIZURE ANALYSIS COMPUTER Grass-Telefactor Product Group | OMB |
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