Effective August 4th, 2020, the US FDA has authorized the Subsalve Oxygen Treatment Hood for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, and has been added to Appendix B of the FDA’s Emergency Use Authorization (EUA).
The Subsalve Oxygen Treatment Hood is a patient interface intended for helmet based Non Invasive Positive Pressure Ventilation (NIPPV) according to clinician established protocols.
This device has not been FDA cleared or approved
This device has been authorized by FDA under an EUA
This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.