BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

    FORTEC MI-305 & 306 DIGITAL THERMOMETER

    K Number: K853317 · Decision Jan 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    173

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    Basic Information

    Device Name
    FORTEC MI-305 & 306 DIGITAL THERMOMETER
    K Number
    K853317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Nam Tai , Ltd.
    Date Received
    August 7, 1985
    Decision Date
    January 27, 1986
    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 Nam Tai , Ltd.

    K Number Device Name
    K873765 FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
    K872584 FORTEC MI-306, MI-327 DIGITAL THERMOMETER
    K851873 FORTEC MI-305