COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 is an FDA 510(k)-cleared medical device (K061902) manufactured by Inditherm Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 2006. Regulation: 8.