510(k) K103318

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

K103318 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR". The FDA issued a decision of Substantially Equivalent on April 7, 2011. 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.