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X-PLO₂R™ Portable Oxygen Concentrator Receives FDA Clearance

Belluscura is excited to announce that the X-PLO2R portable oxygen concentrator has been granted 510(K) clearance from the U.S. Food and Drug Administration (FDA). We are extremely proud to bring this technology to the market, in doing our part to help improve the quality of life for millions of people worldwide who suffer from chronic lung diseases, such as the Chronic Obstructive Pulmonary Disease (COPD), respiratory distress caused by COVID-19, and many other respiratory disorders.

View the full press release and continue to follow Belluscura for future updates.

 

New FDA Guidance Provides a Policy Designed to Expand the Availability of Respiratory Devices, Including Oxygen Concentrators, During the COVID-19 Pandemic

Today, the U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency.

WHITE OAK, MD  (Photo by Sarah Silbiger/Getty Images)

 
The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of devices that facilitate respiration, including ventilators and accessories. Learn more.