PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE

PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE is an FDA 510(k)-cleared medical device (K122121) manufactured by Pulsion Medical Systems SE. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2012. Regulation: 8.