| Ceribell Neurology Review Software (K260998) | Ceribell, Inc. | 2026-06-24 |
| Ceribell Infant Seizure Detection Software (K252070) | Ceribell, Inc. | 2025-11-21 |
| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K252160) | Persyst Development, LLC | 2025-10-31 |
| autoSCORE (V 2.0.0) (K243743) | Holberg Eeg AS | 2025-04-09 |
| Ceribell Seizure Detection Software (K241589) | Ceribell, Inc. | 2025-04-09 |
| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K242446) | Persyst Development Corporation | 2025-01-22 |
| NeuroMatch (K241390) | LVIS Corporation | 2024-11-26 |
| REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408) | Epitel, Inc. | 2024-10-17 |
| encevis (2.1) (K240993) | Ait Austrian Institute of Technology GmbH | 2024-09-27 |
| autoSCORE (K231068) | Holberg Eeg AS | 2024-01-07 |
| REMI AI Discrete Detection Module (K231779) | Epitel, Inc. | 2024-01-03 |
| LVIS NeuroMatch (K222450) | LVIS Corporation | 2023-06-09 |
| Ceribell Status Epilepticus Monitor (K223504) | Ceribell, Inc. | 2023-05-23 |
| Persyst 15 EEG Review and Analysis Software (K222002) | Persyst Development Corporation | 2022-12-30 |
| Encevis (K211452) | Austrian Institute of Technology GmbH | 2021-12-02 |
| Natus NeuroWorks (K200878) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020-05-18 |
| Ceribell Pocket EEG Device (K191301) | Ceribell, Inc. | 2019-09-11 |
| Persyst 14 EEG Review and Analysis Software (K182181) | Persyst Development Corporation | 2018-11-29 |
| encevis (K171720) | Ait Austrian Institute of Technology GmbH | 2018-04-19 |
| Natus NeuroWorks (K180421) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-14 |
| Persyst Mobile App (K171184) | Persyst Development Corporation | 2017-09-21 |
| IdentEvent (K150688) | Optima Neuroscience, Inc. | 2015-11-05 |
| PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE (K151929) | Persyst Development Corporation | 2015-08-12 |
| CLINISCANSM EEG (K141883) | Picofemto, LLC | 2015-05-15 |
| CADWELL SPIKE AND SEIZURE DETECTOR (K140552) | Cadwell | 2014-07-23 |
| PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE (K133793) | Persyst Development Corporation | 2014-05-19 |
| PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE (K132306) | Persyst Development Corp. | 2013-11-21 |
| ICTA (K120260) | Excel-Tech Ltd. (Xltek) | 2012-06-29 |
| NATUS NEUROWORKS, MODEL 104196 (K090019) | Natus Medical, Inc. | 2010-02-22 |
| IDENTEVENT, VERSION 1.0G (K092039) | Optima Neuroscience, Inc. | 2009-10-16 |
| XLTEK CONNEX IP HEADBOX, MODEL 1054 (K042223) | Excel Tech. , Ltd. | 2004-09-16 |
| PERSYST REVEAL (K011397) | Persyst Development Corp. | 2001-08-03 |
| EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) (K010085) | Excel Tech. , Ltd. | 2001-03-15 |
| EEG SPIKE AND EVENT DETECTOR MODULE (K002332) | Excel Tech. , Ltd. | 2000-10-06 |
| HARMONIE SENSA (K960273) | Stellate Systems | 1996-04-04 |
| DIGITRACE HOME VIDEO SYSTEM (K955787) | New England Medical Instruments, Inc. | 1996-02-09 |
| BIO-LOGIC AUTOMATIC EVENT ANALYSIS (K951594) | Bio-Logic Systems Corp. | 1995-08-22 |
| NMI SOFTWARE (K950270) | Nicolet Biomedical, Inc. | 1995-05-15 |
| DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM (K944833) | New England Medical Monitoring Co. | 1995-05-04 |
| PERSYST SPIKE DETECTOR (K950117) | Persyst Consulting Services, Inc. | 1995-04-05 |
| DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX (K910771) | New England Medical Instruments, Inc. | 1991-12-18 |
| SZAC-16 SEIZURE ANALYSIS COMPUTER (K870450) | Grass-Telefactor Product Group | 1987-04-08 |