CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 is an FDA 510(k)-cleared medical device (K060820) manufactured by Suntech Medical, 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 June 6, 2006. Regulation: 8.