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

    HEARTSTART MRX, MODEL M3535A

    K Number: K040404 · Decision May 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    227
    Applicant Total
    111
    Review Days
    77

    Basic Information

    Device Name
    HEARTSTART MRX, MODEL M3535A
    K Number
    K040404
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Received
    February 17, 2004
    Decision Date
    May 4, 2004
    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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