510(k) K800546

BUNN VOLUMAIRE RESPIRATORY EXERCISER by The John Bunn Co. — Product Code BWF

K800546 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN VOLUMAIRE RESPIRATORY EXERCISER". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. The John Bunn Co. has at least 10 other 510(k) clearances on record.