ELECTRO-NERVE STIMULATOR B4/B400

ELECTRO-NERVE STIMULATOR B4/B400 is an FDA 510(k)-cleared medical device (K851185) manufactured by Biomedical Life Systems, 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 22, 1985. Regulation: 8.