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510(k) Data Aggregation

    K Number
    K113095
    Device Name
    E-CARE INFRARED EAR THERMOMETER
    Manufacturer
    E-CARE TECHNOLOGY CORPORATION
    Date Cleared
    2012-03-02

    (135 days)

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

    E-CARE TECHNOLOGY CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600, is an electronic clinical thermometer using an infrared sensor to detect body temperature from auditory canal for people of all ages in the home.
    Device Description
    The E-Care Infrared Ear Thermometer, models LCT-300 and LCT-600 is a hand-held, battery-powered electronic thermometer which uses an infrared sensor (thermopile) to detect body temperature from auditory canal. Its operation is based on measuring infrared radiation from the tympanic membrane and the surrounding tissue. The signal of sensor is calculated and display by an ASIC controlled circuit. This device consists of a thermopile for the measuring sensor, an ASIC controlled circuit for calculating the electrical signal and an LCD to display the measured temperature. By inserting the probe of this infrared ear thermometer into the outer canal, press the measurement button to start measurement. The electronic circuits amplify and calculate the signal of sensor, then display the temperature on LCD display. The total operation takes a few seconds.
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    K Number
    K021753
    Device Name
    E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
    Manufacturer
    E-CARE TECHNOLOGY CORPORATION
    Date Cleared
    2002-08-06

    (69 days)

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

    E-CARE TECHNOLOGY CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
    Device Description
    The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 consists mainly of four parts - an IR detector with a built in ambient temperature sensor, a barrel, an LCD display, and the associated circuit. The ear canal quides sound to the eardrum. which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contacting the eardrum. When measuring, the radiative fluxes transfer from the tympanum through or reflected by the inner surfaces of the barrel to the IR detector. The ambient sensor is built-in and mounted near the IR sensor element to monitor the ambient temperature. To measure core temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a display. The total operation takes a few seconds.
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