CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK

CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK is an FDA 510(k)-cleared medical device (K093389) manufactured by Computerized Screening, 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 November 16, 2009. Regulation: 8.