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

    TISSUE TEMP PROBE

    K Number: K850083 · Decision Mar 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    TISSUE TEMP PROBE
    K Number
    K850083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pat O. Daily
    Date Received
    January 10, 1985
    Decision Date
    March 27, 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 Pat O. Daily

    K Number Device Name
    K851077 CARDIAC COOLING JACKET