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

    LUXTRON MODEL 3100/3101/3102 MULTICHANNEL

    K Number: K923189 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    636

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    Basic Information

    Device Name
    LUXTRON MODEL 3100/3101/3102 MULTICHANNEL
    K Number
    K923189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Luxtron
    Date Received
    June 30, 1992
    Decision Date
    March 28, 1994
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Luxtron

    K Number Device Name
    K861623 MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER
    K841105 MULTICHANNEL 2000 FLUOROPTIC THERMOMET
    K821070 BIOMEDICAL FLUOROPTIC