510(k) K013122

EMS ELECTROSTATIC FLITER AND HME COMBINATION by Engineered Medical Systems — Product Code CAH

K013122 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems for the device "EMS ELECTROSTATIC FLITER AND HME COMBINATION". The FDA issued a decision of Substantially Equivalent on April 19, 2002. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Engineered Medical Systems has at least 10 other 510(k) clearances on record.