BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Monitor, Carbon-Dioxide, Cutaneous

    PMA: P810037 · Supplement: S010 · Decision May 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Monitor, Carbon-Dioxide, Cutaneous
    Trade Name
    KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
    PMA Number
    P810037
    Supplement Number
    S010
    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
    May 22, 1998
    Date Received
    March 14, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for converstion of the stand-alone MicroGas 7640 P02/PC02 Monitor to a plug-in module for the Kolormon Plus host. The device, as modified, will be marketed under the trade name Kontron Kolormon Plus BloodGas Module 7267-505 and is indicated for cutaneous measurement of blood gas tensions (P02 or PC02).

    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