510(k) K121161

EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER by Acta Medical, LLC — Product Code KPE

K121161 is an FDA 510(k) premarket notification submitted by Acta Medical, LLC for the device "EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER". The FDA issued a decision of Substantially Equivalent on July 13, 2012. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Acta Medical, LLC has at least 2 other 510(k) clearances on record.