FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM

FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM is an FDA 510(k)-cleared medical device (K990214) manufactured by Surgical Navigation Technologies, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 1999. Regulation: 8.