510(k) K934355

ELECTROMEDICS BLOOD HEAT EXCHANGER by Electromedics, Inc. — Product Code DTR

K934355 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "ELECTROMEDICS BLOOD HEAT EXCHANGER". The FDA issued a decision of Substantially Equivalent on December 3, 1993. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Electromedics, Inc. has at least 10 other 510(k) clearances on record.