DINAMAP VITAL SIGNS MONITOR MODEL 8100

DINAMAP VITAL SIGNS MONITOR MODEL 8100 is an FDA 510(k)-cleared medical device (K854434) manufactured by Critikon Company, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 1986. Regulation: 8.