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510(k) Data Aggregation

    K Number
    K991725
    Device Name
    SIDESTREAM NEBULIZER
    Manufacturer
    INSPIRED MEDICAL PRODUCTS LTD.
    Date Cleared
    1999-07-30

    (71 days)

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

    INSPIRED MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.
    Device Description
    The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer cleared under K924123. Made of three components - top, baffle, base. Materials in contact with patient - polypropylene. Provided clean, non-sterile.
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