NORODYN 8000 SEMG SYSTEM, ND-8000

NORODYN 8000 SEMG SYSTEM, ND-8000 is an FDA 510(k)-cleared medical device (K992439) manufactured by Myotronics-Noromed, 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 August 12, 1999. Regulation: 8.