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

    MICROTHERM MT-501 & MT-502

    K Number: K854007 · Decision Nov 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    39

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    Basic Information

    Device Name
    MICROTHERM MT-501 & MT-502
    K Number
    K854007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medequi, Division of King Yip Co., Inc.
    Date Received
    September 30, 1985
    Decision Date
    November 8, 1985
    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 Medequi, Division of King Yip Co., Inc.

    K Number Device Name
    K854035 MICRO THERM MT-500 & MT-600