Interesting Note on Belluscura Website14 Aug 2020 17:00
Seem confident of clearance. “While the COVID-19 (Coronavirus) pandemic has been a source of instability and stress beyond our collective imagination, Belluscura’s entire team, research partners and regulatory and manufacturing consultants are diligently working together to soon bring the X-PLO2R portable oxygen concentrator to the market. We will announce publicly when the X-PLO2R receives 510(K) clearance from the US Food and Drug Administration.”