LIFESCOPE 6 OEC-6105

LIFESCOPE 6 OEC-6105 is an FDA 510(k)-cleared medical device (K841502) 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 August 27, 1984. Regulation: 8.