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510(k) Data Aggregation
K Number
K043615Device Name
OXYTEC, MODEL 900
Manufacturer
Date Cleared
2005-02-09
(41 days)
Product Code
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
OXYTEC MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.
Device Description
The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.
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