CPI MODEL 2215/SEAMED MODEL 3400

CPI MODEL 2215/SEAMED MODEL 3400 is an FDA 510(k)-cleared medical device (K910223) manufactured by Seamed 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 March 18, 1991. Regulation: 8.