FDA’s list of Emergency Use Authorizations (EUAs) for Ventilators and Ventilator Accessories has been updated, adding the AustinP51 (resuscitator) to Appendix B of the ventilator EUA. The AustinP51 is a portable emergency-use resuscitator designed to provide either continuous or intermittent ventilatory support for patients requiring mechanical ventilation through volume control. The AustinP51 emergency-use system (EURS) is for use by professionals qualified and trained in the use of general ventilation equipment, or who are specifically trained on the AustinP51 system. This EURS is intended for use in healthcare settings to treat adults during the COVID-19 pandemic.
Appendix B is here:
Original content was first posted here: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas#appendixb
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