CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000

CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 is an FDA 510(k)-cleared medical device (K992575) manufactured by Infimed, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 1999. Regulation: 8.