510(k) K183108

Combined Aerobika OPEP and VersaPAP device by Trudell Medical International — Product Code BWF

K183108 is an FDA 510(k) premarket notification submitted by Trudell Medical International for the device "Combined Aerobika OPEP and VersaPAP device". The FDA issued a decision of Substantially Equivalent on August 16, 2019. 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.