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510(k) Data Aggregation

    K Number
    K033513
    Device Name
    EASI ECG ALGORITHM
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Date Cleared
    2004-01-15

    (70 days)

    Product Code
    DRW
    Regulation Number
    870.2350
    Why did this record match?
    Product Code :

    DRW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. ST. Segment monitoring is restricted to adult patients only. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, including: - Assessment of symptoms that may be related to rhythm disturbances of the heart - -Patients with palpitations - The evaluation of arrhythmias in patients from neonatal to pediatric to adult age - arrhythmia - -- Assessment of efficacy of anti-arrhythmic therapy - -- Assessment of pacemaker function - Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing
    Device Description
    Not Found
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    K Number
    K020456
    Device Name
    EASI 12 LEAD ALGORITHM
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Date Cleared
    2002-07-09

    (148 days)

    Product Code
    DRW, 74D
    Regulation Number
    870.2350
    Why did this record match?
    Product Code :

    DRW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.
    Device Description
    The new device is a modification to previously reviewed submittals containing the EASI algorithm. The modification is a software-based change that slightly improves existing correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement.
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