BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Monitor, Carbon-Dioxide, Cutaneous

    PMA: P800043 · Supplement: S001 · Decision Sep 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Monitor, Carbon-Dioxide, Cutaneous
    Trade Name
    RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
    PMA Number
    P800043
    Supplement Number
    S001
    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
    September 21, 1981
    Date Received
    August 25, 1981
    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