DINAMAP VITAL SIGNS MONITOR, MODEL 8100T

DINAMAP VITAL SIGNS MONITOR, MODEL 8100T is an FDA 510(k)-cleared medical device (K874378) 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 December 29, 1987. Regulation: 8.