KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES

KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES is an FDA 510(k)-cleared medical device (K861629) manufactured by Downs Surgical , Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1986. Regulation: 8.