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510(k) Data Aggregation

    K Number
    K180685
    Device Name
    AS-3XX Series Fingertip Pulse Oximeter
    Date Cleared
    2018-11-29

    (259 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiamen Acurio Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospital-type facilities, and home environments.
    Device Description
    The AS-301/AS-302/AS-301-L/AS-302-L/AS-303/AS-304/AS-304-L/AS-311 Fingertip Pulse Oximeter manufactured by ACURIO provides noninvasive blood oxygen measurement by the dual-wavelength spectrophotometric technique, and shows the results by the OLED. The oximeter is easy to operate, small in volume, light in weight, convenient in carrying, low consumption in design and with strong resistance to ambient light interference. 2pcs of AAA batteries can be continuously used for 20 hours, and the battery voltage can be indicated. The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adults in hospitals, hospital-type facilities, and home environments. The components of the oximeter include the body part and a hanging rope. Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger), to a receiver on the other side. Two beams of different wavelength of lights (660nm red and 895nm near infrared light) can be focused onto a human nail tip through c clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
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    K Number
    K171455
    Device Name
    AT-6XX Series Infrared Thermometer
    Date Cleared
    2018-02-09

    (268 days)

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

    Xiamen Acurio Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is intended for body temperature measurement from the auditory canal for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
    Device Description
    The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. It uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal. Pressing the activation button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
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