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

    E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.

    K Number: K900333 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    50
    Review Days
    83

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    Basic Information

    Device Name
    E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
    K Number
    K900333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Radiometer America, Inc.
    Date Received
    January 23, 1990
    Decision Date
    April 16, 1990
    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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