Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212395
    Device Name
    Nebulizer
    Date Cleared
    2022-03-25

    (235 days)

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

    Shenzhen Homed Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ILI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
    Device Description
    The JLI nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air is forced into the nebulizer through a nozzle cover, 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 JLI nebulizer is disposable, single-patient-use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1