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

    PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

    K Number: K040904 · Decision Sep 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    107
    Review Days
    162

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    Basic Information

    Device Name
    PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
    K Number
    K040904
    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
    Date Received
    April 7, 2004
    Decision Date
    September 16, 2004
    Product Code
    NSA
    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
    NSA Over-The-Counter Automated External Defibrillator

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