510(k) K181660

Acapella Choice Blue Vibratory PEP Device by Smiths Medical — Product Code BWF

K181660 is an FDA 510(k) premarket notification submitted by Smiths Medical for the device "Acapella Choice Blue Vibratory PEP Device". The FDA issued a decision of Substantially Equivalent on October 24, 2019. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Smiths Medical has at least 2 other 510(k) clearances on record.