510(k) K240778

Vivo 1, Vivo 2 by Breas Medical AB — Product Code MNS

K240778 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "Vivo 1, Vivo 2". The FDA issued a decision of Substantially Equivalent on December 13, 2024. 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.