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510(k) Data Aggregation

    K Number
    K230379
    Device Name
    Portable (Ultrasonic) Nebulizer
    Manufacturer
    Dongguan SIMZO Electronic Technology Co.Ltd.
    Date Cleared
    2023-11-27

    (287 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan SIMZO Electronic Technology Co.Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable (Ultrasonic) nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/ institutional settings, home, schools, and long-term care facilities. It is not intended for use with Pentamidine.
    Device Description
    The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.
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    K Number
    K211583
    Device Name
    Infrared Thermometer, Model: HW-1
    Manufacturer
    Dongguan SIMZO Electronic Technology Co.Ltd.
    Date Cleared
    2021-09-03

    (102 days)

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

    Dongguan SIMZO Electronic Technology Co.Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Thermometer is intermittent measurement of ear and forehead temperature at home or hospital. It can be used for anybody, such as infants, children and adults.
    Device Description
    Infrared thermometer, model:HW-1
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    K Number
    K173048
    Device Name
    No-contact Forehead Thermometer
    Manufacturer
    Dongguan SIMZO Electronic Technology Co.Ltd.
    Date Cleared
    2018-12-06

    (434 days)

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

    Dongguan SIMZO Electronic Technology Co.Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    The Non-contact Forehead Thermometers are hand-held, battery powered devices designed to measure human body temperature. The subject devices are Infrared thermometers that convert a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in the distance from subject's forehead up to 5-8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S). The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection with the distance from forehead up to 5~8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S) and compensation of the temperature reading.
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