BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

    K Number: K103706 · Decision Aug 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    247

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    Basic Information

    Device Name
    THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
    K Number
    K103706
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Cardiac Systems, Inc.
    Date Received
    December 20, 2010
    Decision Date
    August 24, 2011
    Product Code
    QYX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QYX Outpatient Cardiac Telemetry

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