510(k) K123400

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE by Trudell Medical Intl. — Product Code BWF

K123400 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE". The FDA issued a decision of Substantially Equivalent on May 16, 2013. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Trudell Medical Intl. has at least 10 other 510(k) clearances on record.