O2 OASYS Oral / Nasal Airway System
The O2 OASYS Oral / Nasal Airway System is cleared as a 510 K Medical Device (#K030440) by the ENT and Dental Divisions of the FDA: 1) Mandibular Repositioner for treatment of Snoring and Sleep Apnea; 2) Nasal Dilator for improved breathing through the nose. It also treats Sleep Disordered Breathing by addressing Upper Airway Resistance in the nasal region. The Lingual Tongue Button component is optional, but adds tongue training and repositioning for improved tongue placement, better swallowing and improved sleep treatment results, ….even in Severe OSA patients.
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