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510(k) Data Aggregation

    K Number
    K111246
    Device Name
    SPIRALE DRUG DELIVERY SYSTEM
    Date Cleared
    2012-08-10

    (464 days)

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

    ARMSTRONG MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.
    Device Description
    The purpose of a drug nebuliser device is to facilitate the nebulisation of respiratory drugs and non-pharmacological (placebo) solutions and to allow the transfer of these preparations to patients via the drug nebuliser. Usage is predominantly for patients receiving treatment in anaesthetic and intensive care settings within hospital theatres, intensive care units, and accident and emergency departments. Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.
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