8100/8500 VITAL SIGNS MONITOR

8100/8500 VITAL SIGNS MONITOR is an FDA 510(k)-cleared medical device (K012059) manufactured by Criticare Systems, 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 July 31, 2001. Regulation: 8.