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

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    K Number: K103567 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    14
    Review Days
    106

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    Basic Information

    Device Name
    LIFEPAK 15 MONITOR/DEFIBRILLATOR
    K Number
    K103567
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Physio-Control, Inc.
    Date Received
    December 6, 2010
    Decision Date
    March 22, 2011
    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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    Other Clearances by Physio-Control, Inc.

    K Number Device Name
    K253099 LIFEPAK 15 AC Power Adapter (41577-000333)
    K240156 LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
    K182503 Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
    K142430 LIFEPAK 15 monitor/defibrillator
    K130454 LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
    K123597 TRUECPR COACHING DEVICE
    K122600 LIFEPAK 1000 DEFIBRILLATOR
    K102972 LIFEPAK 12
    K102757 LIFENET SYSTEM
    K093925 LIFENET SYSTEM
    Search all 14 clearances from Physio-Control, Inc. →