BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    HEARTSTART MRX MONITOR/DEFIBRILLATOR

    K Number: K062233 · Decision Nov 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    71
    Review Days
    112

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    Basic Information

    Device Name
    HEARTSTART MRX MONITOR/DEFIBRILLATOR
    K Number
    K062233
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    August 2, 2006
    Decision Date
    November 22, 2006
    Product Code
    MKJ
    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
    MKJ Automated External Defibrillators (Non-Wearable)

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