SEP PROGRAMMER FOR PUCK U & UD FILMCHANG

SEP PROGRAMMER FOR PUCK U & UD FILMCHANG is an FDA 510(k)-cleared medical device (K842903) manufactured by Elema-Schonander, 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 August 20, 1984. Regulation: 8.