510(k) K141943

BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM by Breathe Technologies — Product Code CBK

K141943 is an FDA 510(k) premarket notification submitted by Breathe Technologies for the device "BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 12, 2015. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Breathe Technologies has at least 7 other 510(k) clearances on record.