510(k) K111473

UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR by Impact Instrumentation, Inc. — Product Code CBK

K111473 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR". The FDA issued a decision of Substantially Equivalent on February 16, 2012. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Impact Instrumentation, Inc. has at least 10 other 510(k) clearances on record.