510(k) K090113

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

K090113 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "BREAS VIVO 40 SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 2009. 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.