DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 is an FDA 510(k)-cleared medical device (K992638) 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 February 23, 2000. Regulation: 8.