UNI-FRAME HEAD IMMOBILIZATION SYSTEM

UNI-FRAME HEAD IMMOBILIZATION SYSTEM is an FDA 510(k)-cleared medical device (K933227) manufactured by Medtec, 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 July 17, 1994. Regulation: 8.