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510(k) Data Aggregation
K Number
K080256Device Name
PULMODYNE CHF FLOW GENERATOR SYSTEM
Manufacturer
PULMODYNE
Date Cleared
2008-05-09
(99 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
PULMODYNE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide CPAP to spontaneously breathing adult patients in the hospital and pre-hospital (EMS) environment.
Device Description
The Pulmodyne CHF Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 150 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube. The Pulmodyne CHF Flow Generator incorporates several components:
Flow generator (two styles - fixed flow and variable flow) .
Patient interface mask .
PEEP valve .
Circuit / tubing and connectors .
Air entrainment filter .
The Pulmodyne CHF Flow Generator is multi-patient, reusable and can be cleaned while the other components: circuit, mask, entrainment filter, and PEEP valve are disposable, single patient use.
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