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510(k) Data Aggregation

    K Number
    K161325
    Device Name
    CliniCloud Non-contact Thermometer, Model SPL1024
    Manufacturer
    STETHOCLOUD PTY. LTD (CLINICLOUD)
    Date Cleared
    2016-06-22

    (41 days)

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

    STETHOCLOUD PTY. LTD (CLINICLOUD)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.
    Device Description
    The CliniCloud Non-Contact Thermometer Model SPL1024 (abbreviated 'CliniCloud Non-Contact Thermometer') is a battery powered Bluetooth Low Energy (BLE) enabled portable infrared thermometer intended for the measurement of human body temperature for persons of all ages. It features no physical buttons or a display and must be used in conjunction with the CliniCloud App on a compatible BLE enabled smartphone. The CliniCloud App is free to download. When power is applied to the device via 2 AAA batteries, the CliniCloud Non-Contact Thermometer starts to advertise via BLE, and can establish a BLE connection with BLE enabled smart phones with the CliniCloud app. The user could then request the CliniCloud non-contact thermometer to take temperature readings from within the CliniCloud app. The measured temperatures are sent back to the smart phone via the established Bluetooth link and displayed on the smartphone's display in the CliniCloud app. The CliniCloud Non-Contact Thermometer uses a medical grade MLX90614ESF-DCC thermopile sensor supplied by Melexis to passively measure object surface temperature using infrared radiation emitted by patients. The sensor also measures the ambient temperature with a built-in thermistor. The sensor is factory calibrated to meet consensus standard ASTM E1965-98. Upon receiving a request from the CliniCloud APP over the established BLE connection the onboard Nordic Semiconductor NRF51822 BLE SOC microcontroller communicates with the thermopile (MLX90614ESF-DCC) over the 12C bus and sends the received temperature readings including the object surface temperature and the ambient temperature to the CliniCloud app via the established BLE connection. On the smartphone app, the well-known heat loss equation is used to perform conversion of forehead surface temperature to oral equivalent temperature.
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