510(k) K091557

LUNG FLUTE THERAPEUTIC by Medical Acoustics — Product Code BWF

K091557 is an FDA 510(k) premarket notification submitted by Medical Acoustics for the device "LUNG FLUTE THERAPEUTIC". The FDA issued a decision of Substantially Equivalent on January 4, 2010. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Medical Acoustics has at least 1 other 510(k) clearance on record.