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510(k) Data Aggregation

    K Number
    K073625
    Device Name
    MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
    Manufacturer
    GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES
    Date Cleared
    2008-01-25

    (30 days)

    Product Code
    DPS, DHX, DQK
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
    Device Description
    The MAC 5500 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and the patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5500 can deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 system acquires ECG data using the CAM14 patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5500 delivers 12 or 15 lead ECG's on full-size reports. The MAC 5500 incorporates a alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, an integrated thermal writer and removable data storage. Additionally, the MAC 5500 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.
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