G.E. MONITROL 90 AND G.E. MONITROL 15

G.E. MONITROL 90 AND G.E. MONITROL 15 is an FDA 510(k)-cleared medical device (K902989) manufactured by Electromek Diagnostic Systems, 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 October 28, 1990. Regulation: 8.