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510(k) Data Aggregation

    K Number
    K091794
    Device Name
    CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
    Manufacturer
    Date Cleared
    2010-01-28

    (225 days)

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

    STEVE ISLAVA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes inhalation solutions to a patient using a small volume nebulizer. The device is single patient use.
    Device Description
    The Care2 Medical Small Volume Nebulizer is a single patient use device. The device is filled with a liquid medication and connected to an air source via flexible tubing. Once the gas comes in contact with the liquid medication, the gas shatters the liquid into small particles. These particles then hit a baffle which further reduces the size of the particles. The smaller particles are administrated to the patient as the patient breathes. The larger particles settle inside the device returning the mist to a liquid to repeat the process until a majority of the medication is nebulized. The Care2 Medical Nebulizer is unique in that it has a side port which allows the user to add medication to the nebulizer without removing the top. The Small Volume Nebulizer is packaged non-sterile in a polyethylene bag.
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