HEAT EXCHANGER, DISP., OMNITHERM

HEAT EXCHANGER, DISP., OMNITHERM is an FDA 510(k)-cleared medical device (K772117) manufactured by Scimed Life Systems, 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 March 1, 1978. Regulation: 8.