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    K Number
    K142059
    Device Name
    FOX MOBILE
    Manufacturer
    VECTURA GMBH
    Date Cleared
    2015-01-09

    (164 days)

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

    VECTURA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FOX MOBILE inhalation system is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, sub-acute institution, or hospital environments. It is intended for patients 3 years and older who can coordinate breathing.
    Device Description
    The FOX MOBILE is a single patient, multi-use, handheld inhalation system to deliver medications which are to be aerosolized. The system includes: - A vibrating mesh nebulizer - LEDs for user feedback - . Flow limitation valve (LIMIX) - Air control
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