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510(k) Data Aggregation
K Number
K060067Device Name
MASKMEDIC CONCEPT NASAL MASK
Manufacturer
Date Cleared
2006-07-14
(186 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MASKMEDIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive air treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use
Device Description
The device is a silicone elastomer nasal mask composed of a moulded, form fitting face mask, connected to standard 16 mm ventilator tubing via a standard 22 mm terminal fitting and fitted with a neoprene harness.
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