ELECTRON WEDGE MODEL MT-EW-1000

ELECTRON WEDGE MODEL MT-EW-1000 is an FDA 510(k)-cleared medical device (K981992) manufactured by Med-Tec,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 December 14, 1998. Regulation: 8.