BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    PMA: P110024 · Supplement: S003 · Decision Nov 17, 2021
    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
    S003
    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
    November 17, 2021
    Date Received
    August 25, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a texture on the sealing surface of the ResQPOD ITD 16 diaphragm, a component of the ResQCPR System.

    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