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510(k) Data Aggregation

    K Number
    K042364
    Device Name
    PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
    Manufacturer
    Date Cleared
    2004-09-30

    (30 days)

    Product Code
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAMONT MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For long term unattended EEG or other electrophysiological signal monitoring and recording. This device is intended for use by physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologist or the equivalent or Ph.D. level Electroencephalographers. We recommend placement of electrodes in accordance with the 10.20 International System.
    Device Description
    Like the predicate WARATAH® and Cardinal® Digital EEG and Sleep Acquisition Devices (WARATAH® Devices), the PANBUS® Digital EEG and Sleep Acquisition Devices (PANBUS® Devices) are provided to Original Equipment Manufactures (OEM) for creation of an electroencephalography (EEG) recording system. Significant PANBUS® Devices are: I ) Personal computer (PC) interface board; 2) Electrode interface connection (Jackbox); 3) Communication protocol and port (PANBUS); 4) Amplifier(s); 5) Electrode lead wire sets.
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