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510(k) Data Aggregation
K Number
K051988Device Name
OXY-SERVE II OXYGEN CONSERVING REGULATOR
Manufacturer
Date Cleared
2005-09-21
(61 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
SUPERIOR PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Oxy-Serve II Oxygen Conserving Regulator is intended as an oxygen conserving pressure regulator for ambulatory patients. The Conserving Regulator delivers a prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.
Device Description
The Oxy-Serve II Oxygen Conserving Regulator is a high pressure oxygen regulator integrated with a conserving device to deliver oxygen during the inhalation phase of a patients breathing cycle, thereby extending the useful life of an oxygen cylinder.
The Oxy-Serve II is constructed of aluminum with brass high pressure chamber components. The device is pneumatic and requires no electrical power source. An indexable control knob selects from 11 flow rates ranging from 1 to 6 LPM in .5 LPM increments. Two outlet ports are connectable using a dual lumen cannula. One port senses the inhalation of the patient thus initiating the selected flow to the patient during the full inhalation cycle. Flow ceases at the end of the inhalation cycle. The second port delivers the oxygen.
The device can operate as a conserving regulator, or as a standard continuous flow regulator operable by sliding a switch on the face of the regulator housing. In continuous mode the sensing diaphragm control component is bypassed and a continuous flow of oxygen is delivered at the flow selected by the indexable control knob through the outlet port.
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