MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)

MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) is an FDA 510(k)-cleared medical device (K884913) manufactured by Merit Medical 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 April 17, 1989. Regulation: 8.