MODEL 1220, OR E-NET (54-62 CM)

MODEL 1220, OR E-NET (54-62 CM) is an FDA 510(k)-cleared medical device (K961609) manufactured by Physiometrix, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 1996. Regulation: 8.