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    K Number
    K170886
    Device Name
    HOMED Mesh Nebulizer
    Manufacturer
    Shenzhen Homed Medical Device Co,.Ltd.
    Date Cleared
    2018-06-21

    (451 days)

    Product Code
    CAF
    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 HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.
    Device Description
    The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
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