BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P200005 · Decision Jan 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
    PMA Number
    P200005
    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
    January 9, 2024
    Date Received
    February 3, 2020
    Expedited Review
    N
    Docket Number
    24M-0760

    Advisory Committee Statement

    for the TZ Medical Adult Multi-Function Defibrillation Electrodes and Adaptors and TZ Medical Pediatric Multi-Function Defibrillation Electrodes and Adaptors

    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)