510(k) K220565

Hudson RCI Triflo II Incentive Deep Breathing Exerciser by Medline Industries, Inc. — Product Code BWF

K220565 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Hudson RCI Triflo II Incentive Deep Breathing Exerciser". The FDA issued a decision of Substantially Equivalent on October 25, 2022. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.