BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR is an FDA 510(k)-cleared medical device (K110645) manufactured by Sonosite,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 June 2, 2011. Regulation: 8.