EUA (Emergency Use Authorization) by FDA

EUA-Notice:
"FDA has determined that the iBreeze PAP model(s) meet the criteria for
safety, performance and labeling set forth in Section II and Appendix A
of the EUA."

Source: Resvent-iBreeze PAP EUA-Notice

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories

Manufacturer: Resvent; Product Name: iBreeze PAP 

Source: Ventilators and Ventilator Accessories EUAs

* iBreeze PAP
(iBreeze 20A) has been authorized by FDA under an EUA.

Designated medical devices listed by Canada

This
iBreeze CPAP System (model 20A) manufactured by Resvent Medical
Technology Co., Ltd. is authorized by Health Canada under Exceptional
Importation.

Medical Device: iBreeze CPAP System (model 20A); MDEL: 19863

Source: List of Medical Devices for Exceptional Importation and Sale

CE

Source: EC Certificate

The device should only be purchased and used in accordance with local laws and regulations.

Manufacturer: Resvent Medical Technology Co., Ltd.