CS/3 ARRHYTHMIA WORKSTATION

CS/3 ARRHYTHMIA WORKSTATION is an FDA 510(k)-cleared medical device (K974747) manufactured by Datex-Engstrom, 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 April 22, 1998. Regulation: 8.