C-ERA-100 COMPUTERIZED ELECTRIC RESPON

C-ERA-100 COMPUTERIZED ELECTRIC RESPON is an FDA 510(k)-cleared medical device (K792085) manufactured by Micro-Shev , Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 1979. Regulation: 8.