CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER

CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER is an FDA 510(k)-cleared medical device (K851613) manufactured by Centrimed Corp.. 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 18, 1985. Regulation: 8.