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510(k) Data Aggregation

    K Number
    K971994
    Device Name
    B-D ASSURE EAR THERMOMETER
    Date Cleared
    1998-05-01

    (337 days)

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

    BECTON DICKINSON CONSUMER PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The B-D Assure Ear Thermometer is designed for home use to measure body temperature from the tympanic membrane. The B-D Assure Ear Thermometer is designed for measuring body temperature in a home setting.
    Device Description
    The Becton Dickinson Infrared Thermometer is a device that measures patient body temperature by quantifying the infrared emission from the tympanic membrane. In clinical application the end of the infrared thermometer is placed in the outer portion of the auditory canal, where the sensor can get a good view of the tympanic membrane. Placing the probe is very similar to the maneuver used to visualize the ear drum using an otoscope. There is no risk of eardrum injury because the probe is not long enough or small enough to be inserted too deep into the ear canal. The most advantageous feature of infrared tympanic thermometry is that it takes very little time. Readings can be taken in a few seconds.
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