510(k) K053607

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

K053607 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 March 16, 2006. 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.