ORG-8200A UNIVERSAL SIGNAL HOUSING

ORG-8200A UNIVERSAL SIGNAL HOUSING is an FDA 510(k)-cleared medical device (K912744) manufactured by Nihon Kohden America, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 1991. Regulation: 8.