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510(k) Data Aggregation

    K Number
    K980214
    Device Name
    EXCEL NEURO WORKS
    Manufacturer
    EXCEL TECH. LTD.
    Date Cleared
    1998-04-21

    (90 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXCEL NEURO WORKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NeuroWorks EEG is an electroencephalograph which is designed to display the electrical signals of the brain.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device named "NeuroWorks EEG". It's a regulatory approval document and does not contain information about acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

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