Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160306
    Device Name
    Cloud Smart Thermometer
    Manufacturer
    GUANGZHOU BOSMA TECHNOLOGY CO LTD
    Date Cleared
    2016-12-13

    (313 days)

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

    GUANGZHOU BOSMA TECHNOLOGY CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cloud Smart Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human axillary temperature continuously via wireless signal transmission of the measuring result. Meanwhile, the device is reusable and is intended for axillary temperature monitoring for persons over two years old, and it is used for household and medical institutions.
    Device Description
    The Cloud Smart Thermometer (WT001-1) which is a combination device of thermometer and Bluetooth communication unit is to be worn in the axillary temperature continuously for household and medical institutions. To start the monitoring operation, switch the thermometer on and place it on the plaster (which is a waterproof medical dressing), and then paste the plaster 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 measure the body temperature by means of testing the thermistor's resistance value and calculates the body temperature every four seconds continuously and sends the temperature data to the receiver through Bluetooth connection. The thermometer uses a CR2025 battery for operation. When the battery capacity is below 90% rated voltage, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver, then the receiver will send out a warning. Meanwhile, the thermometer is capable of monitoring the axillary temperature continuously for 24 hours and it can also save measured data in the Cloud for remote real-time monitoring.
    Ask a Question

    Page 1 of 1