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

    EAR THERMOMETER, MODELS ST613C AND ST613F

    K Number: K011254 · Decision Jul 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    EAR THERMOMETER, MODELS ST613C AND ST613F
    K Number
    K011254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mesure Technology
    Date Received
    April 24, 2001
    Decision Date
    July 10, 2001
    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 Mesure Technology

    K Number Device Name
    K013779 THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
    K011585 FAST THERMOMETER MODELS ST713C AND ST713F
    K981337 DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
    K962520 DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A