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510(k) Data Aggregation

    K Number
    K982479
    Device Name
    EXCEL AMBULATORY EEG
    Manufacturer
    EXCEL TECH. LTD.
    Date Cleared
    1998-10-14

    (90 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K980214
    Why did this record match?
    Device Name :

    EXCEL AMBULATORY EEG

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

    The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).

    When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.

    Device Description

    The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The documents are primarily an FDA 510(k) clearance letter and an "Indications For Use" statement for the Excel Ambulatory EEG device.

    The documents confirm the device's clearance and intended use but do not include any performance data, acceptance criteria, study methodologies, or results.

    Therefore, I cannot provide the requested information in the format specified.

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