SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)

SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) is an FDA 510(k)-cleared medical device (K964784) manufactured by Quinton, 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 12, 1997. Regulation: 8.