Oxygen Concentrator-P2-O5E

The Oxygen Concentrator P2-O5E is a portable medical device that provides supplemental low-flow oxygen to adults using molecular sieve pressure swing adsorption technology. The device is not intended for life support and does not provide patient monitoring capabilities.

The device operates at 0.5–5.0 L/min continuous flow with oxygen concentration of 90%–3%/+6% at all settings and output pressure of 4–7 PSI. It is powered by AC (100–240 VAC, 50–60 Hz), weighs 15.8 kg, and produces ≤60 dB(A) acoustic noise. It includes analog and digital electronics with microprocessor control and uses PET panels and PC+ABS housing.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, ISO 80601-2-69, ISO 18562-1/2/3, ISO 10993-1/5/10/23 for biocompatibility, electrical safety, electromagnetic compatibility, and breathing gas pathway emissions.

The P2-O5E is substantially equivalent to the predicate DOGS-S (K150930) because both use molecular sieve adsorption for oxygen concentration, share the same product code (CAW) and regulatory class (II), and provide supplemental oxygen via nasal cannula. Differences in flow rate, oxygen concentration, power supply, and alarms do not raise new safety or effectiveness questions because the device passed all applicable IEC and ISO standards and comprehensive bench testing.