S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 is an FDA 510(k)-cleared medical device (K002116) manufactured by Medical Device Consultants, 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 August 8, 2000. Regulation: 8.