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510(k) Data Aggregation

    K Number
    K133105
    Device Name
    BREEZE NEBULIZER (NBR-10X)
    Date Cleared
    2014-06-24

    (267 days)

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

    DIGIO2 INTERNATIONAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (ages 2 years old and above) and adult patients in the home. It is not intended for use with Pentamidine.
    Device Description
    Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer that delivers aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. It is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. They are identical in purpose, function, core technology and method of operation. Breeze nebulizer (NBR-101) is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available and to turn off automatically. The open button is made of soft materials and gives off an ice blue light, coupled with an overall elegant white exterior. Breeze Nebulizer (NBR-101) is battery powered, 4 "AAA" and the dimensions is 58(W) X 145(H) X 70(D). The medication container capacity is 8ml maximum and the residual volume is approximately 0.1ml.
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    K Number
    K112189
    Device Name
    THERMO PAL INFRARED EAR THERMOMETER
    Date Cleared
    2012-01-13

    (168 days)

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

    DIGIO2 INTERNATIONAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the ear tympanic.
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    K Number
    K091430
    Device Name
    CARE PAL, MODEL CPW-10X
    Date Cleared
    2009-08-21

    (99 days)

    Product Code
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIGIO2 INTERNATIONAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Care Pal (Model no. CPW-10X) is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.
    Device Description
    The Care Pal ("CP") remote patient monitoring system is for use in non-clinical settings as an accessory device to collect and transmit historical patient information to healthcare providers. It is intended to be used in combination with a variety of external devices. The CP remote patient monitoring system serves as the remote communication link between compatible external devices and the compatible healthcare facility at another location. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgment. The CP appliance contains software that can be activated to function with specific medical devices (including blood glucose meter, blood pressure and weight scale). The CP appliance with device connectivity retrieves data from a specific medical device and transmits to a remote healthcare provider using standard digital communication technologies. The CP appliance is not used directly on the patient, and poses no significant risk to the patient or other people within the patient's home. Care Pal provides interfaces to the following connecting peripheral devices and back end server as well a. BT Selected device (Brand/Model): weight scale, A&D/UC-321PBT - b. USB Selected device (Brand/Model): glucose meter, Johnson & Johnson LifeScan / OneTouch Ultra II (K053529) c. RS-232 (Serial Port) Selected device (Brand/Model): blood pressure meter, A&D UA-787PC (K012013) d. Internet (Ethernet/wireless) connection to backend server
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