FDA Product Code
FDA Product Code OMB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | 2026-06-24 | Traditional | PDF ↗ |
| K252070 | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | 2025-11-21 | Traditional | PDF ↗ |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | 2025-10-31 | Traditional | PDF ↗ |
| K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | 2025-04-09 | Traditional | PDF ↗ |
| K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | 2025-04-09 | Traditional | PDF ↗ |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | 2025-01-22 | Traditional | PDF ↗ |
| K241390 | NeuroMatch | LVIS Corporation | 2024-11-26 | Traditional | PDF ↗ |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024-10-17 | Traditional | PDF ↗ |
| K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024-09-27 | Traditional | PDF ↗ |
| K231068 | autoSCORE | Holberg Eeg AS | 2024-01-07 | Traditional | PDF ↗ |
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | 2024-01-03 | Traditional | PDF ↗ |
| K222450 | LVIS NeuroMatch | LVIS Corporation | 2023-06-09 | Traditional | PDF ↗ |
| K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023-05-23 | Traditional | PDF ↗ |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | 2022-12-30 | Traditional | PDF ↗ |
| K211452 | Encevis | Austrian Institute of Technology GmbH | 2021-12-02 | Traditional | PDF ↗ |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020-05-18 | Traditional | PDF ↗ |
| K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019-09-11 | Traditional | PDF ↗ |
| K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | 2018-11-29 | Traditional | PDF ↗ |
| K171720 | encevis | Ait Austrian Institute of Technology GmbH | 2018-04-19 | Traditional | PDF ↗ |
| K180421 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-14 | Special | PDF ↗ |
| K171184 | Persyst Mobile App | Persyst Development Corporation | 2017-09-21 | Traditional | PDF ↗ |
| K150688 | IdentEvent | Optima Neuroscience, Inc. | 2015-11-05 | Traditional | PDF ↗ |
| K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corporation | 2015-08-12 | Special | PDF ↗ |
| K141883 | CLINISCANSM EEG | Picofemto, LLC | 2015-05-15 | Traditional | PDF ↗ |
| K140552 | CADWELL SPIKE AND SEIZURE DETECTOR | Cadwell | 2014-07-23 | Traditional | PDF ↗ |
| K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corporation | 2014-05-19 | Traditional | PDF ↗ |
| K132306 | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corp. | 2013-11-21 | Traditional | PDF ↗ |
| K120260 | ICTA | Excel-Tech Ltd. (Xltek) | 2012-06-29 | Traditional | PDF ↗ |
| K090019 | NATUS NEUROWORKS, MODEL 104196 | Natus Medical, Inc. | 2010-02-22 | Traditional | PDF ↗ |
| K092039 | IDENTEVENT, VERSION 1.0G | Optima Neuroscience, Inc. | 2009-10-16 | Traditional | PDF ↗ |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | Excel Tech. , Ltd. | 2004-09-16 | Special | PDF ↗ |
| K011397 | PERSYST REVEAL | Persyst Development Corp. | 2001-08-03 | Traditional | PDF ↗ |
| K010085 | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-03-15 | Traditional | PDF ↗ |
| K002332 | EEG SPIKE AND EVENT DETECTOR MODULE | Excel Tech. , Ltd. | 2000-10-06 | Traditional | PDF ↗ |
| K960273 | HARMONIE SENSA | Stellate Systems | 1996-04-04 | Traditional | PDF ↗ |
| K955787 | DIGITRACE HOME VIDEO SYSTEM | New England Medical Instruments, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K951594 | BIO-LOGIC AUTOMATIC EVENT ANALYSIS | Bio-Logic Systems Corp. | 1995-08-22 | Traditional | PDF ↗ |
| K950270 | NMI SOFTWARE | Nicolet Biomedical, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K944833 | DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM | New England Medical Monitoring Co. | 1995-05-04 | Traditional | PDF ↗ |
| K950117 | PERSYST SPIKE DETECTOR | Persyst Consulting Services, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K910771 | DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX | New England Medical Instruments, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K870450 | SZAC-16 SEIZURE ANALYSIS COMPUTER | Grass-Telefactor Product Group | 1987-04-08 | Traditional | PDF ↗ |
Product code OMB · Class II · Neurology. Data: openFDA.