BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P190007 · Decision Aug 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    Cardinal Health Multifunctional Defibrillation Electrode
    PMA Number
    P190007
    Device Class
    FDA Class 3
    Product Code
    MKJ
    Generic Name
    Automated external defibrillators (non-wearable)
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 7, 2020
    Date Received
    March 7, 2019
    Expedited Review
    N
    Docket Number
    20M-1752

    Advisory Committee Statement

    Approval for the Cardinal Health Multifunctional Defibrillation Electrodes. These devices are indicated for: The Multifunctional Defibrillation Electrodes are intended to transfer energy from a cardiac defibrillator or pacer to the body of a patient for the purpose of defibrillation, synchronized cardioversion, pacing, or for ECG monitoring. The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control LIFEPAK (LP) defibrillators are compatible with Physio-Control / Stryker LP 15, LP 20, LP 20E, LP 1000, LP CR Plus, and LP Express defibrillators with the exception of the Kendall 1010P Adult Multi-Function Defibrillation Electrode, which is compatible with Physio-Control LP 20 and LP 20e defibrillators and the Physio-Control FAST-PATCH® cable.The Medi-Trace Cadence Pediatric Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control / Stryker defibrillators are compatible with Physio-Control LP 15, LP 20, and LP 20e defibrillators.The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Zoll defibrillators are compatible with Zoll R Series BLS, R Series Plus, R Series ALS, X Series, and Propaq MD defibrillators.The Physio-Control/Stryker QUIK-COMBO Adult pacing/defibrillation/ECG electrodes and QUIK-COMBO Pediatric pacing/defibrillation/ECG electrodes are compatible with LP 15, LP 20, and LP 20e defibrillators. The Physio-Control/Stryker QUIK-COMBO pacing/defibrillation/ECG electrode with REDI-PAK Preconnect system is compatible with LP 15, LP 20, LP 20e, LP 1000, LP CR Plus, and LP EXPRESS defibrillators.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)