510(k) K071702

BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 by Breas Medical AB — Product Code MNT

K071702 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40". The FDA issued a decision of Substantially Equivalent on February 15, 2008. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Breas Medical AB has at least 10 other 510(k) clearances on record.