THE BAGNOLI-2 EMG SYSTEM

THE BAGNOLI-2 EMG SYSTEM is an FDA 510(k)-cleared medical device (K945286) manufactured by Delsys, 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 September 14, 1995. Regulation: 8.