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510(k) Data Aggregation

    K Number
    K143615
    Device Name
    Antistatic Compact Space Chamber
    Manufacturer
    MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
    Date Cleared
    2016-01-26

    (403 days)

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

    MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The antistatic Compact Space Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The device is intended for use in neonates, infants, children, adolescents and adults. The intended environments for use include home, hospitals and clinics.
    Device Description
    Antistatic Compact Space Chamber
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