Search Results
Found 1 results
510(k) Data Aggregation
K Number
K110713Device Name
WATERPAP VALVE
Manufacturer
AIRWAYS DEVELOPMENT, LLC
Date Cleared
2011-09-12
(181 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
AIRWAYS DEVELOPMENT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.
Device Description
The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure above atmospheric in constant flow conditions.
Ask a Question
Page 1 of 1