Product Code: OLT
FDA class 2
21 CFR 882.1400
Non-Normalizing Quantitative Electroencephalograph Software
Neurology
The Non-Normalizing Quantitative Electroencephalograph Software (product code OLT) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It analyzes electroencephalograph data using conventional methodology to output and display standard EEG parameters for interpretation by a qualified user, without comparison to a normative database. The device is eligible for third-party review and is not an implant or life-sustaining device.
510(k)s
52
FEI Numbers
69
Registration Numbers
69
Unique Applicants
44
Years Active
43
Basic Information
- Product Code
- OLT
- Device Class
- FDA class 2
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
Definition
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 52 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240593 | VEEGix EEG System | Aug 23, 2024 | Substantially Equivalent | NeuroServo Inc. |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Nov 30, 2022 | Substantially Equivalent | Neurosoft Ltd. |
| K213299 | Wireless EEG System | May 11, 2022 | Substantially Equivalent | Pascall Systems Inc |
| K191322 | E-EEGX, N-EEGX | Jan 22, 2020 | Substantially Equivalent | GE Healthcare Finland Oy |
| K192572 | CNS Envision | Dec 17, 2019 | Substantially Equivalent | Moberg Research, Inc. |
| K190760 | Cadwell Bolt Software | Nov 23, 2019 | Substantially Equivalent | Cadwell Industries, Inc. |
| K143487 | Lifelines iEEG | Aug 21, 2015 | Substantially Equivalent | KVIKNA EHF |
| K142834 | DiscoverEEG System, Model DE-401 | Jun 23, 2015 | Substantially Equivalent | NeuroWave Systems Inc. |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | Jun 19, 2015 | Substantially Equivalent | NEUROSOFT LTD |
| K142064 | GALILEO NT | Feb 13, 2015 | Substantially Equivalent | EB NEURO, S.P.A. |
| K141316 | COGNISION EEG/EP SYSTEM | Feb 13, 2015 | Substantially Equivalent | NEURONETRIX SOLUTIONS |
| K131882 | GEODESICEEG SYSTEM 400 SERIES (GES 400) | Feb 12, 2014 | Substantially Equivalent | ELECTRICAL GEODESICS, INC. |
| K123665 | LIFELINES IEEG | Mar 25, 2013 | Substantially Equivalent | KVIKNA EHF |
| K091963 | VIGILANT EEG MONITOR, VIGILANT 2.0 | Nov 06, 2009 | Substantially Equivalent | INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
| K082886 | ZOOM-100DC | Aug 10, 2009 | Substantially Equivalent | BRAINSCOPE COMPANY, INC. |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Aug 29, 2008 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K072382 | MODEL I-2000 MONITOR | Feb 15, 2008 | Substantially Equivalent | INFINITE BIOMEDICAL TECHNOLOGIES |
| K063797 | GEODESIC EEG SYSTEM 300 | Jan 25, 2007 | Substantially Equivalent | ELECTRICAL GEODESICS, INCORPORATED |
| K062533 | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 | Dec 22, 2006 | Substantially Equivalent | NEUROVIRTUAL USA, INC. |
| K051883 | DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. | Aug 05, 2005 | Substantially Equivalent | GE HEALTHCARE |
| K033010 | BRM2 BRAIN MONITOR | Oct 10, 2003 | Substantially Equivalent | BRAINZ INSTRUMENTS LTD. |
| K030489 | BRM2 BRAIN MONITOR | May 02, 2003 | Substantially Equivalent | BRAINZ INSTRUMENTS LTD. |
| K023536 | NUAMPS | Jan 15, 2003 | Substantially Equivalent | NEUROSCAN |
| K001564 | SCAN LT40 (40 CHANNELS) | Nov 24, 2000 | Substantially Equivalent | NEURO SCAN LABS |
| K001324 | SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) | Jul 11, 2000 | Substantially Equivalent | NEURO SCAN LABS |
| K000892 | DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES | Jun 16, 2000 | Substantially Equivalent | DATEX-OHMEDA, INC. |
| K000068 | COMPUMEDICS E-SERIES EEG SYSTEM | Mar 13, 2000 | Substantially Equivalent | COMPUMEDICS NEURO SCIENCE PTY LTD. |
| K991012 | SIEMENS INFINITY EEG POD | Jun 24, 1999 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K982351 | LUNA | Jul 29, 1998 | Substantially Equivalent | STELLATE SYSTEMS |
| K955577 | ECLIPSE VERSION 3.0 | Sep 20, 1996 | Substantially Equivalent | STELLATE SYSTEMS |
| K954157 | DG PORTABLE SYSTEM | Jan 17, 1996 | Substantially Equivalent | MEDELEC LTD. |
| K952347 | A-1050 EEG MONITOR | Jan 16, 1996 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K953799 | DG EXAMINER PLUS | Nov 08, 1995 | Substantially Equivalent | MEDELEC LTD. |
| K951724 | QUANTITATIVE EEG ANALYSIS SOFTWARE | Jul 14, 1995 | Substantially Equivalent | NEUROCONCEPTS, INC. |
| K940811 | BRAINTRACE | May 02, 1995 | Substantially Equivalent | BRAINSTORMS MONITORING CORP. |
| K915820 | NEUROSEARCH-24 OR NRS-24 | Feb 08, 1995 | Substantially Equivalent | LEXICOR MEDICAL TECHNOLOGY, INC. |
| K934050 | TOPOGRAPHIC BRAIN MAPPING OPTION | Feb 03, 1994 | Substantially Equivalent | BIOSOUND, INC. |
| K923043 | SPECTRAL EEG MONITOR MODEL A1000 | Dec 03, 1992 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K913051 | SPECTRAL EEG MONITOR MODEL B500 | Aug 20, 1991 | Substantially Equivalent | BIOMETRAK CORP. |
| K894889 | TECA NEUROMAPPER 386 | Dec 22, 1989 | Substantially Equivalent | TECA, INC. |
| K894088 | TECA NEUROMAPPER 1620, BRAIN MAPPER | Nov 15, 1989 | Substantially Equivalent | TECA, INC. |
| K874733 | GUARDIAN, EEG BRAIN MONITORING SYSTEM | Feb 29, 1988 | Substantially Equivalent | TRACOR NORTHERN, INC. |
| K863783 | HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM | Mar 03, 1987 | Substantially Equivalent | HZI RESEARCH CENTER |
| K863650 | QUANTIMAP III | Sep 26, 1986 | Substantially Equivalent | QUANTIFIED SIGNAL IMAGING, INC. |
| K860378 | MIND MAP (20 CHANNEL EEG) | Aug 12, 1986 | Substantially Equivalent | MIND SYSTEMS CORP. |
| K853420 | CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS | Feb 07, 1986 | Substantially Equivalent | ALVAR |
| K852587 | CDSA(COLOR DENSITY, SPECTRAL ARRRAY) | Aug 16, 1985 | Substantially Equivalent | TRACOR NORTHERN, INC. |
| K850541 | SLEEP STAGER | Aug 02, 1985 | Substantially Equivalent | OXFORD MEDILOG, INC. |
| K843808 | DUAL CHENNEL BRAIN ACTIVITY MONITOR | Nov 08, 1984 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K841790 | LIFESCAN EEG MONITOR | Jul 12, 1984 | Substantially Equivalent | NEUROMETRICS |
| K820653 | OTE BIOMEDICA BERG FOURIER ANALYZER | May 07, 1982 | Substantially Equivalent | DEL MAR AVIONICS |
| K810359 | ELECTROENCEPHALOMYOGRAPH | Mar 13, 1981 | Substantially Equivalent | THORACEL RESEARCH LABS. |
FEI Numbers
This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.