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510(k) Data Aggregation
K Number
K982243Device Name
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
Manufacturer
CANOGEN INTERNATIONAL LTD.
Date Cleared
1998-11-19
(147 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
CANOGEN INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Canogen Portable Oxygen Generator, Model 615 is intended to produce oxygen for emergency use.
Device Description
The Canogen Portable Oxygen Generator, Model 615 provides an average of 6.5 liters a minute for a minimum of 15 minutes, through a chemical reaction. The Canogen Portable Oxygen Generator, Model 615 consists of three parts. The first part is a reaction vessel in which the chemical reaction takes place. The reaction vessel may be reused. The second part is the cartridge containing the chemicals required to generate the oxygen produced by this device. The third part of the generator consists of the plastic tubing and gas mask which are attached to the outlet of the generator.
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