BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM

    K Number: K093154 · Decision Feb 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    28
    Review Days
    122

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    Basic Information

    Device Name
    TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
    K Number
    K093154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiometer Medical Aps
    Date Received
    October 6, 2009
    Decision Date
    February 5, 2010
    Product Code
    LKD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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