EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 is an FDA 510(k)-cleared medical device (K971570) manufactured by Quinton Electrophysiology 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 December 28, 1997. Regulation: 8.