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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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    K Number
    K122252
    Device Name
    SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
    Manufacturer
    MEDICAL DEVELOPMENTS INTERNATIONAL
    Date Cleared
    2013-11-13

    (474 days)

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

    MEDICAL DEVELOPMENTS INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Space Chamber Plus and Compact Space Chamber Plus are intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The devices are 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 intended environments for use include home, hospitals and clinics.
    Device Description
    The Space Chamber Plus and Compact Space Chamber Plus are devices designed to assist patients with inhaling aerosolized medication dispensed through a Metered Dose Inhaler. The devices consist of a cylindrical chamber with an opening at each end. One opening is for the aerosol medication to be inserted, the other is tapered into a mouthpiece for inhalation. The mouthpiece can be used with or without a mask. The Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.
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