510(k) K173918

VersaPAP Positive Airway Pressure (PAP) Device by Trudell Medical International — Product Code BWF

K173918 is an FDA 510(k) premarket notification submitted by Trudell Medical International for the device "VersaPAP Positive Airway Pressure (PAP) Device". The FDA issued a decision of Substantially Equivalent on August 17, 2018. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Trudell Medical International has at least 8 other 510(k) clearances on record.