MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)

MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) is an FDA 510(k)-cleared medical device (K973230) 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 November 24, 1997. Regulation: 8.