BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    PMA: P110024 · Supplement: S001 · Decision Jun 15, 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
    Supplement Number
    S001
    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
    June 15, 2015
    Date Received
    May 12, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE TIMING LIGHT SWITCH EXTENSION ON THE RESQPOD ITD 16.

    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