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

    CLINICAL ELECTRONIC THERMOMETER

    K Number: K841780 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    67

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    Basic Information

    Device Name
    CLINICAL ELECTRONIC THERMOMETER
    K Number
    K841780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Fidelity Medical, Inc.
    Date Received
    April 30, 1984
    Decision Date
    July 6, 1984
    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 Fidelity Medical, Inc.

    K Number Device Name
    K983088 INSTACINE D-2000
    K942558 INSTACINE
    K942504 INSTASPOT
    K941917 FLUOROPLUA CARDIAC AND/OR INSTAVIEW
    K903774 LP-PLUS
    K872928 LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
    K864614 LP-3 ELECTROCARDIOGRAPH