510(k) K014102

PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 by Atos Medical AB — Product Code JOH

K014102 is an FDA 510(k) premarket notification submitted by Atos Medical AB for the device "PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251". The FDA issued a decision of Substantially Equivalent on February 21, 2002. 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.