Regulatory & Compliance

EUA (Emergency Use Authorization) by FDA

EUA-Notice: "FDA has determined that the Beyond C20A CPAP model, Beyond B30P BiPAP model meet the criteria for safety, performance and labeling set forth in Section II and Appendix A of the EUA."

Source: Beyond C20A CPAP EUA - Notice

Source: Beyond B30P BiPAP EUA - Notice

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