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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OLT FDA class 2

    Non-Normalizing Quantitative Electroencephalograph Software

    Neurology

    View full classification →

    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) Clearances

    50+ matches
    K Number
    Device Name
    VEEGix EEG System
    Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
    Wireless EEG System
    E-EEGX, N-EEGX
    CNS Envision
    Cadwell Bolt Software
    Lifelines iEEG
    DiscoverEEG System, Model DE-401
    NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
    GALILEO NT
    COGNISION EEG/EP SYSTEM
    GEODESICEEG SYSTEM 400 SERIES (GES 400)
    LIFELINES IEEG
    VIGILANT EEG MONITOR, VIGILANT 2.0
    ZOOM-100DC
    NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
    MODEL I-2000 MONITOR
    GEODESIC EEG SYSTEM 300
    BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
    DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
    BRM2 BRAIN MONITOR
    BRM2 BRAIN MONITOR
    NUAMPS
    SCAN LT40 (40 CHANNELS)
    SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
    DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
    COMPUMEDICS E-SERIES EEG SYSTEM
    SIEMENS INFINITY EEG POD
    LUNA
    ECLIPSE VERSION 3.0
    DG PORTABLE SYSTEM
    A-1050 EEG MONITOR
    DG EXAMINER PLUS
    QUANTITATIVE EEG ANALYSIS SOFTWARE
    BRAINTRACE
    NEUROSEARCH-24 OR NRS-24
    TOPOGRAPHIC BRAIN MAPPING OPTION
    SPECTRAL EEG MONITOR MODEL A1000
    SPECTRAL EEG MONITOR MODEL B500
    TECA NEUROMAPPER 386
    TECA NEUROMAPPER 1620, BRAIN MAPPER
    GUARDIAN, EEG BRAIN MONITORING SYSTEM
    HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
    QUANTIMAP III
    MIND MAP (20 CHANNEL EEG)
    CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
    CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
    SLEEP STAGER
    DUAL CHENNEL BRAIN ACTIVITY MONITOR
    LIFESCAN EEG MONITOR

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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