FDA Product Code
FDA Product Code OLT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | 2026-09-16 | Traditional | PDF ↗ |
| K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026-08-19 | Special | PDF ↗ |
| K253767 | UB ERP System | Universal Brain | 2026-06-30 | Traditional | PDF ↗ |
| K251881 | HippoMind (v1.0) | Hippoclinic | 2025-12-03 | Traditional | PDF ↗ |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation | 2025-10-09 | Traditional | PDF ↗ |
| K240593 | VEEGix EEG System | NeuroServo, Inc. | 2024-08-23 | Traditional | PDF ↗ |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft , Ltd. | 2022-11-30 | Traditional | PDF ↗ |
| K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022-05-11 | Traditional | PDF ↗ |
| K191322 | E-EEGX, N-EEGX | GE Healthcare Finland Oy | 2020-01-22 | Traditional | PDF ↗ |
| K192572 | CNS Envision | Moberg Research, Inc. | 2019-12-17 | Traditional | PDF ↗ |
| K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | 2019-11-23 | Traditional | PDF ↗ |
| K143487 | Lifelines iEEG | Kvikna Ehf | 2015-08-21 | Traditional | PDF ↗ |
| K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015-06-23 | Traditional | PDF ↗ |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | Neurosoft , Ltd. | 2015-06-19 | Traditional | PDF ↗ |
| K141316 | COGNISION EEG/EP SYSTEM | Neuronetrix Solutions | 2015-02-13 | Traditional | PDF ↗ |
| K142064 | GALILEO NT | Eb Neuro S.P.A. | 2015-02-13 | Traditional | PDF ↗ |
| K131882 | GEODESICEEG SYSTEM 400 SERIES (GES 400) | Electrical Geodesics, Inc. | 2014-02-12 | Traditional | PDF ↗ |
| K123665 | LIFELINES IEEG | Kvikna Ehf | 2013-03-25 | Traditional | PDF ↗ |
| K091963 | VIGILANT EEG MONITOR, VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | 2009-11-06 | Traditional | PDF ↗ |
| K082886 | ZOOM-100DC | Brainscope Company, Inc. | 2009-08-10 | Traditional | PDF ↗ |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Nihon Kohden America, Inc. | 2008-08-29 | Special | PDF ↗ |
| K072382 | MODEL I-2000 MONITOR | Infinite Biomedical Technologies | 2008-02-15 | Traditional | PDF ↗ |
| K063797 | GEODESIC EEG SYSTEM 300 | Electrical Geodesics, Incorporated | 2007-01-25 | Special | PDF ↗ |
| K062533 | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 | Neurovirtual USA, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K051883 | DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. | GE Healthcare | 2005-08-05 | Special | PDF ↗ |
| K033010 | BRM2 BRAIN MONITOR | Brainz Instruments , Ltd. | 2003-10-10 | Traditional | PDF ↗ |
| K030489 | BRM2 BRAIN MONITOR | Brainz Instruments , Ltd. | 2003-05-02 | Traditional | PDF ↗ |
| K023536 | NUAMPS | Neuroscan | 2003-01-15 | Abbreviated | PDF ↗ |
| K001564 | SCAN LT40 (40 CHANNELS) | Neuro Scan Labs | 2000-11-24 | Traditional | PDF ↗ |
| K001324 | SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) | Neuro Scan Labs | 2000-07-11 | Traditional | PDF ↗ |
| K000892 | DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES | Datex-Ohmeda, Inc. | 2000-06-16 | Traditional | PDF ↗ |
| K000068 | COMPUMEDICS E-SERIES EEG SYSTEM | Compumedics Neuro Science Pty , Ltd. | 2000-03-13 | Traditional | PDF ↗ |
| K991012 | SIEMENS INFINITY EEG POD | Siemens Medical Solutions USA, Inc. | 1999-06-24 | Traditional | PDF ↗ |
| K982351 | LUNA | Stellate Systems | 1998-07-29 | Special | PDF ↗ |
| K955577 | ECLIPSE VERSION 3.0 | Stellate Systems | 1996-09-20 | Traditional | PDF ↗ |
| K954157 | DG PORTABLE SYSTEM | Medelec , Ltd. | 1996-01-17 | Traditional | PDF ↗ |
| K952347 | A-1050 EEG MONITOR | Aspect Medical Systems, Inc. | 1996-01-16 | Traditional | PDF ↗ |
| K953799 | DG EXAMINER PLUS | Medelec , Ltd. | 1995-11-08 | Traditional | PDF ↗ |
| K951724 | QUANTITATIVE EEG ANALYSIS SOFTWARE | Neuroconcepts, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K940811 | BRAINTRACE | Brainstorms Monitoring Corp. | 1995-05-02 | Traditional | PDF ↗ |
| K915820 | NEUROSEARCH-24 OR NRS-24 | Lexicor Medical Technology, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K934050 | TOPOGRAPHIC BRAIN MAPPING OPTION | Biosound, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K923043 | SPECTRAL EEG MONITOR MODEL A1000 | Aspect Medical Systems, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K913051 | SPECTRAL EEG MONITOR MODEL B500 | Biometrak Corp. | 1991-08-20 | Traditional | PDF ↗ |
| K894889 | TECA NEUROMAPPER 386 | Teca, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K894088 | TECA NEUROMAPPER 1620, BRAIN MAPPER | Teca, Inc. | 1989-11-15 | Traditional | PDF ↗ |
| K874733 | GUARDIAN, EEG BRAIN MONITORING SYSTEM | Tracor Northern, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K863783 | HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM | Hzi Research Center | 1987-03-03 | Traditional | PDF ↗ |
| K863650 | QUANTIMAP III | Quantified Signal Imaging, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K860378 | MIND MAP (20 CHANNEL EEG) | Mind Systems Corp. | 1986-08-12 | Traditional | PDF ↗ |
| K853420 | CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS | Alvar | 1986-02-07 | Traditional | PDF ↗ |
| K852587 | CDSA(COLOR DENSITY, SPECTRAL ARRRAY) | Tracor Northern, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K850541 | SLEEP STAGER | Oxford Medilog, Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K843808 | DUAL CHENNEL BRAIN ACTIVITY MONITOR | Datex Division Instrumentarium Corp. | 1984-11-08 | Traditional | PDF ↗ |
| K841790 | LIFESCAN EEG MONITOR | Neurometrics | 1984-07-12 | Traditional | PDF ↗ |
| K820653 | OTE BIOMEDICA BERG FOURIER ANALYZER | Del Mar Avionics | 1982-05-07 | Traditional | PDF ↗ |
| K810359 | ELECTROENCEPHALOMYOGRAPH | Thoracel Research Labs. | 1981-03-13 | Traditional | PDF ↗ |
Product code OLT · Class II · Neurology. Data: openFDA.