BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Monitor, Carbon-Dioxide, Cutaneous

    PMA: P810037 · Supplement: S007 · Decision Nov 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Monitor, Carbon-Dioxide, Cutaneous
    Trade Name
    KONTRON CUTANEOUS PCO2 MONITOR
    PMA Number
    P810037
    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
    November 25, 1997
    Date Received
    September 18, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modification of MicroGas 7640 with COMBI 81. The device, as modified, will be marketed under the trade name MicroGas 7650 with COMBI M82.

    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