510(k) K150173

Aerobika OPEP Devive with Manometer by Trudell Medical International — Product Code BWF

K150173 is an FDA 510(k) premarket notification submitted by Trudell Medical International for the device "Aerobika OPEP Devive with Manometer". The FDA issued a decision of Substantially Equivalent on October 15, 2015. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Trudell Medical International has at least 8 other 510(k) clearances on record.