ASCOM CLINICALCONNEX CARDIOMAX

ASCOM CLINICALCONNEX CARDIOMAX is an FDA 510(k)-cleared medical device (K103634) manufactured by Ascom (Us), 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 February 22, 2011. Regulation: 8.