AMERITEK SURE-POINT TRACKER SYSTEM

AMERITEK SURE-POINT TRACKER SYSTEM is an FDA 510(k)-cleared medical device (K030518) manufactured by Amertek Medical, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2003. Regulation: 8.