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510(k) Data Aggregation

    K Number
    K132761
    Device Name
    WIRELESS THERMOMETER
    Manufacturer
    RAIING MEDICAL COMPANY
    Date Cleared
    2014-07-08

    (307 days)

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

    RAIING MEDICAL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless Thermometer is a battery-operated 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 intended for armpit temperature monitoring for persons over two years old.
    Device Description
    The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through Bluetooth connection. The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
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