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510(k) Data Aggregation

    K Number
    K162041
    Device Name
    Airworks Nebulizer pe1200m
    Manufacturer
    Convexity Scientific LLC
    Date Cleared
    2017-05-02

    (281 days)

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

    Convexity Scientific LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airworks™ Nebulizer pel 200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.
    Device Description
    The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. The Airworks™ Nebulizer pe1200m uses a vibrating mesh technology, which is comprised of a medicalgrade stainless steel disk containing 1,000 precision-formed holes. When energy is applied, the disk vibrates approximately 110,000 times per second. This rapid vibration causes a difference in pressure on either side of each aperture, drawing liquid through the holes to form consistently sized droplets. The Airworks™ Nebulizer pe1200m is lightweight, compact and virtually silent. A rechargeable lithiumion battery powers the device.
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