BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Monitor, Carbon-Dioxide, Cutaneous

    PMA: P840037 · Supplement: S001 · Decision Nov 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Monitor, Carbon-Dioxide, Cutaneous
    Trade Name
    MODEL 515 NEONATAL MONIOTR
    PMA Number
    P840037
    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
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 19, 1986
    Date Received
    June 19, 1986
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    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