SAMS 8000 CARDIOPLEGIA MONITOR

SAMS 8000 CARDIOPLEGIA MONITOR is an FDA 510(k)-cleared medical device (K960916) manufactured by 3M Health Care, Sarns. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 1996. Regulation: 8.