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

    Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

    K Number: K182503 · Decision Jun 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    14
    Review Days
    264

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    Basic Information

    Device Name
    Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
    K Number
    K182503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Physio-Control, Inc.
    Date Received
    September 12, 2018
    Decision Date
    June 3, 2019
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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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)
    K142430 LIFEPAK 15 monitor/defibrillator
    K130454 LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
    K123597 TRUECPR COACHING DEVICE
    K122600 LIFEPAK 1000 DEFIBRILLATOR
    K103567 LIFEPAK 15 MONITOR/DEFIBRILLATOR
    K102972 LIFEPAK 12
    K102757 LIFENET SYSTEM
    K093925 LIFENET SYSTEM
    Search all 14 clearances from Physio-Control, Inc. →