BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Monitor, Carbon-Dioxide, Cutaneous

    PMA: P810022 · Supplement: S007 · Decision Dec 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Monitor, Carbon-Dioxide, Cutaneous
    Trade Name
    TCO2M MODEL 818 MONITOR
    PMA Number
    P810022
    Supplement Number
    S007
    Device Class
    FDA Class 2
    Product Code
    LKD
    Generic Name
    MONITOR, CARBON-DIOXIDE, CUTANEOUS
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 4, 1984
    Date Received
    October 19, 1984
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LKD Monitor, Carbon-Dioxide, Cutaneous