Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103839
    Device Name
    BEHIND EAR GENTLE TOUCH THERMOMETER
    Manufacturer
    Date Cleared
    2011-06-06

    (158 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.
    Device Description
    The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature. The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1