BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    UP-GRADE FOREHEAD THERMOMETER

    K Number: K032362 · Decision Dec 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    126

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    Basic Information

    Device Name
    UP-GRADE FOREHEAD THERMOMETER
    K Number
    K032362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medisim, Ltd.
    Date Received
    July 31, 2003
    Decision Date
    December 4, 2003
    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 Medisim, Ltd.

    K Number Device Name
    K150160 Temple Touch Pro (TTP) Non-invasive temperature monitoring system
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    K051422 DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
    K012217 M5T INSTANT FEVER THERMOMETER
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