510(k) K072590

INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM by Event Medical, Inc. — Product Code CBK

K072590 is an FDA 510(k) premarket notification submitted by Event Medical, Inc. for the device "INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on January 4, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Event Medical, Inc. has at least 6 other 510(k) clearances on record.