ELECTROMEDICS BLOOD HEAT EXCHANGER

ELECTROMEDICS BLOOD HEAT EXCHANGER is an FDA 510(k)-cleared medical device (K934355) manufactured by Electromedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1993. Regulation: 8.