510(k) K061057

BREAS ISLEEP 20+ by Breas Medical AB — Product Code BZD

K061057 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "BREAS ISLEEP 20+". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Breas Medical AB has at least 10 other 510(k) clearances on record.