510(k) K060790

BREAS, MODEL HA01 by Breas Medical AB — Product Code BTT

K060790 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "BREAS, MODEL HA01". The FDA issued a decision of Substantially Equivalent on May 25, 2006. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Breas Medical AB has at least 10 other 510(k) clearances on record.