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510(k) Data Aggregation

    K Number
    K082380
    Device Name
    VICARDIO 12B
    Date Cleared
    2008-12-03

    (106 days)

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

    ENERGY-LAB TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The vicardio is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.
    Device Description
    The vicardio is a digital, PC-based electrocardiograph with a special isolation amplifier between the patient and the computer.
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