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510(k) Data Aggregation
K Number
K111246Device Name
SPIRALE DRUG DELIVERY SYSTEM
Manufacturer
Date Cleared
2012-08-10
(464 days)
Regulation Number
868.5630Why 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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