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510(k) Data Aggregation

    K Number
    K093172
    Device Name
    QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
    Manufacturer
    DYNACARDIA, INC.
    Date Cleared
    2010-01-20

    (104 days)

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

    DYNACARDIA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the QED 1000 is to record 12-lead ECG signals from adult patients from body surface ECG electrodes. This device can acquire, display, record, and store these ECG signals for review by the user. The QED 1000 is intended to be used in healthcare facilities by trained healthcare professionals. A qualified physician must over-read all computer-generated tracings. The QED 1000 is designed for use by a qualified physician to evaluate the electrocardiogram of adult patients as part of clinical diagnosis.
    Device Description
    The Quantitative Electocardiographic Detector (QED) is a 12-lead resting electrocardiograph. It is a reusable device for acquiring, displaying, and storing the 12-lead electrocardiogram.
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