BIO-CAL 370 HEATER/COOLER

BIO-CAL 370 HEATER/COOLER is an FDA 510(k)-cleared medical device (K894980) manufactured by Bio Medicus, 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 November 1, 1989. Regulation: 8.