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510(k) Data Aggregation

    K Number
    K050143
    Device Name
    OMNIPRO SYSTEM
    Date Cleared
    2005-02-01

    (11 days)

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

    MAYS AND ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OmniPro™ System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.
    Device Description
    The OmniAmp is a dual-purpose amplifier system for use in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center. The system hardware consists of an amplifier module with electrode inputs, an interface module and a personal computer (PC) with a data acquisition (DAQ) board. Electrodes and sensors on the patient are connected to the amplifier module, which in turn is connected via a multiconductor cable to an interface box. The interface box is connected via a second multiconductor cable to the DAQ board in the PC, which is used to process display and store the EEG or PSG data. DC power to the amplifier is supplied from the DAQ board through the multiconductor cable. The PC at the patient location is connected to a second PC at a remote monitoring center via modem over the public switched telephone network (PSTN). In EEG studies, the remote PC is used to monitor the waveform data as it is collected by the patient PC to ensure adequate electrode placement and signal quality. At the end of the recorded data is transferred from the patient PC to the remote PC. where it is analyzed and stored.
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