BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    PMA: P110024 · Supplement: S004 · Decision Aug 23, 2023
    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
    S004
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 23, 2023
    Date Received
    July 26, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a new automated flow tester for ResQPOD ITD16.

    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