BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

    K Number: K980756 · Decision Nov 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    136
    Review Days
    251

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    Basic Information

    Device Name
    COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
    K Number
    K980756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    February 27, 1998
    Decision Date
    November 5, 1998
    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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