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510(k) Data Aggregation
K Number
K050918Device Name
KOO AMERICAS VALVE PEEP, MODEL KM-809
Manufacturer
Date Cleared
2005-06-06
(55 days)
Product Code
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
KOO AMERICAS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Koo Americas valve PEEP is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H2O pressure.
Device Description
The Koo Americas Valve PEEP is an adjustable valve, which is placed in a circuit and provides for positive end expiratory pressure for the patient. It is spring actuated and is a single patient use device. It is clear in construction allowing confirmation of functionality. Graduated markings allow for confirmation of settings. A convenience connector is provided to allow for conversion to 22mm. The connector is a male 30mm that connects to the female Peep Valve to provide 22mm.
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