ELECTRODE JUNCTION BOX, MODEL JE-921A

ELECTRODE JUNCTION BOX, MODEL JE-921A is an FDA 510(k)-cleared medical device (K050833) manufactured by Nihon Kohden America, 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 April 28, 2005. Regulation: 8.