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510(k) Data Aggregation

    K Number
    K142541
    Device Name
    POCKET NEB
    Manufacturer
    MicroVaper Devices
    Date Cleared
    2016-01-22

    (499 days)

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

    MicroVaper Devices

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB may be used in adults or children 2 years of age and older. The POCKET NEB is a portable unit for use in and out of the home environment. The POCKET NEB is not intended as a life sustaining or life-supporting device. The POCKET NEB is not intended for use with Pentamidine.
    Device Description
    The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB is a portable unit.
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