D6ZO DISPOSABLE HEAT EXCHANGER

D6ZO DISPOSABLE HEAT EXCHANGER is an FDA 510(k)-cleared medical device (K813264) 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 July 5, 1982. Regulation: 8.