510(k) K190630

SolidAIRity III Airway Stabilization System by Securisyn Medical, LLC — Product Code BTR

K190630 is an FDA 510(k) premarket notification submitted by Securisyn Medical, LLC for the device "SolidAIRity III Airway Stabilization System". The FDA issued a decision of Substantially Equivalent on October 9, 2019. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730.