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510(k) Data Aggregation
K Number
K191875Device Name
Owgels Oxygen Concentrator
Date Cleared
2020-07-20
(374 days)
Product Code
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Life Light Electronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.
Device Description
Owgels Oxygen Concentrator, Model : OZ-5-02TW0 adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. The concentrator can generate oxygen with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is around 19kg.
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