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510(k) Data Aggregation
K Number
K020362Device Name
P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
Manufacturer
ON SITE GAS SYSTEMS INC.
Date Cleared
2002-02-12
(8 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
ON SITE GAS SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.
Device Description
The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxvaen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.
The variations of the device are to allow for greater total flow, to accommodate more cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.
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