ALPHA MX (20)/ULTRA PC (30)

ALPHA MX (20)/ULTRA PC (30) is an FDA 510(k)-cleared medical device (K970163) manufactured by Technical Medical Products, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 1997. Regulation: 8.