ENRAF-NONIUS ENDOMED 182 SYSTEM

ENRAF-NONIUS ENDOMED 182 SYSTEM is an FDA 510(k)-cleared medical device (K003744) manufactured by Henley Healthcare, 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 February 19, 2002. Regulation: 8.