510(k) K060657

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. by Breas Medical AB — Product Code BZD

K060657 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.". The FDA issued a decision of Substantially Equivalent on August 18, 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.