COSMED QUARK C12/QUARK T12

COSMED QUARK C12/QUARK T12 is an FDA 510(k)-cleared medical device (K014262) manufactured by Cosmed Srl. 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 25, 2002. Regulation: 8.