510(k) K151404

ProTrach Dualcare by Atos Medical AB — Product Code JOH

K151404 is an FDA 510(k) premarket notification submitted by Atos Medical AB for the device "ProTrach Dualcare". The FDA issued a decision of Substantially Equivalent on February 12, 2016. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Atos Medical AB has at least 10 other 510(k) clearances on record.