TYSHAK, MODEL 102 AND Z-MED, MODEL 302

TYSHAK, MODEL 102 AND Z-MED, MODEL 302 is an FDA 510(k)-cleared medical device (K991977) manufactured by NuMED, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2000. Regulation: 8.