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

    STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

    K Number: K080461 · Decision Mar 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    13
    Applicant Total
    107
    Review Days
    22

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    Basic Information

    Device Name
    STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
    K Number
    K080461
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems
    Date Received
    February 20, 2008
    Decision Date
    March 13, 2008
    Product Code
    MLD
    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
    MLD Monitor, St Segment With Alarm

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