510(k) K813476

OHIO VOLUME INCENTIVE SPIROMETER by Airco/Ohio Medical Products — Product Code BWF

K813476 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "OHIO VOLUME INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.