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510(k) Data Aggregation

    K Number
    K121696
    Device Name
    WIRELESS THERMOMETER
    Manufacturer
    RALING MEDICAL COMPANY
    Date Cleared
    2012-10-11

    (126 days)

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

    RALING MEDICAL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless Thermometer, model WTM-B530-I, is a battery-operated elected electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old.
    Device Description
    The proposed device is use to measure, monitor and record the body temperature in armpit, and transmits the data recorded to receiver for display by wireless (blue tooth) way in real time.
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