510(k) K060546

BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 by Breas Medical AB — Product Code MNS

K060546 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30". The FDA issued a decision of Substantially Equivalent on May 26, 2006. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Breas Medical AB has at least 10 other 510(k) clearances on record.