510(k) K926250

ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR by Electromedics, Inc. — Product Code DTN

K926250 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR". The FDA issued a decision of Substantially Equivalent on February 19, 1993. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Electromedics, Inc. has at least 10 other 510(k) clearances on record.