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510(k) Data Aggregation

    K Number
    K042631
    Device Name
    EAR THERMOMETER, MODEL WL-320X
    Manufacturer
    Date Cleared
    2004-12-22

    (86 days)

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

    INNOVATECH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ear Thermometer, models WL-320X are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
    Device Description
    battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
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    K Number
    K023500
    Device Name
    DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
    Manufacturer
    Date Cleared
    2002-12-13

    (56 days)

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

    INNOVATECH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) WL-3306 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.
    Device Description
    The Digital Clinical Thermometers, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) -- controlled circuit, which is considered the hard-wire control instead of programmable control. Basically WL-3305 and WL-3306 have the same intended use and operation function except for the different measuring range caused by some small different design in IC circuit. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, it was designed and verified according to the US standard ASTM E1112-98.
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