510(k) K182847

Hudson RCI Voldyne Volumetric Exerciser by Teleflexmedical, Inc. — Product Code BWF

K182847 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Hudson RCI Voldyne Volumetric Exerciser". The FDA issued a decision of Substantially Equivalent on July 1, 2019. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.