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ISO13485 Certified 3L Home Oxygen Concentrator for Health. ISO13485 & CE Certified: FDA and CE certified medical device ensuring safety and quality standards for home care. Advanced Safety Alarms: Features low oxygen flow, power, and overload alarms with automatic stop protection. Real-Time Monitoring: Includes oxygen concentration display with red, yellow, and green indication lights. OEM/ODM Available: Supports customized branding and design options for medical homecare equipment.