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510(k) Data Aggregation
K Number
K112564Device Name
QUIXIE NEBULIZER
Manufacturer
Date Cleared
2011-11-23
(82 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ODYSSEY MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Quixie is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or healthcare professional. The intended environments for use include the home, hospitals, and clinics. The Quixie is intended for multiple use by a single patient.
Device Description
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