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510(k) Data Aggregation

    K Number
    K192971
    Device Name
    Nebulizer Kit
    Date Cleared
    2021-07-08

    (624 days)

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

    Excellentcare Medical (Huizhou) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nebulizer kit is used to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways. The Nebulizer kit is intended for adult consistent with the indication in hospitals and sub-acute institutions.
    Device Description
    The nebulizer kit is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air or oxygen is forced into the nebulizer through a converging nozzle, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The nebulizer kit is single-patient, multi-use; it requires a cleaning and disinfection process before each use, and the service life is for 30 aerosol treatments.
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