MAST FOR BASIC HEATER-COOLER UNIT 16-09-00

MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 is an FDA 510(k)-cleared medical device (K883332) manufactured by Shiley, 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 September 25, 1988. Regulation: 8.