BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    PMA: P110024 · Decision Mar 6, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
    Trade Name
    RESQCPR SYSTEM
    PMA Number
    P110024
    Device Class
    FDA Class 3
    Product Code
    PIZ
    Generic Name
    Combination compression/decompression manual chest pump with impedance respiratory valve
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 6, 2015
    Date Received
    June 15, 2011
    Expedited Review
    Y
    Docket Number
    15M-0738

    Advisory Committee Statement

    APPROVAL FOR THE RESQCPR SYSTEM. THIS DEVICE IS INDICATED FOR USE AS A CPR ADJUNCT TO IMPROVE THE LIKELIHOOD OF SURVIVAL IN ADULT PATIENTS WITH NON-TRAUMATIC CARDIAC ARREST.

    Classifications

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

    Product Code Device Name
    PIZ Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve