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SafeBVM's Adult Sotair Device Receives FDA 510(k) Clearance
SafeBVM™ is a small business founded and led by a diverse group of clinicians. Their mission is to prevent patient harm during manual ventilation.
Having received over $3.5 million in grants from reputable organizations such as the American Heart Association, National Institutes of Health, National Science Foundation, and U.S. Air Force, they have implemented research, education, and training campaigns. Their first product, the ADULT Sotair™ device, was recently FDA 510(k) cleared and will be available at the end of 2022.
Sotair limits high flow rates delivered from the manual resuscitator, thus minimizing complications such as gastric insufflation that arise from over-ventilation.
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