BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    HEARTEVENT, MODEL AT

    K Number: K072385 · Decision Jan 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    292
    Applicant Total
    1
    Review Days
    140

    Basic Information

    Device Name
    HEARTEVENT, MODEL AT
    K Number
    K072385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DIAGNOSTIC DEVICES PTY LTD
    Date Received
    August 24, 2007
    Decision Date
    January 11, 2008
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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