IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER is an FDA 510(k)-cleared medical device (K882138) manufactured by Imex Medical Systems, 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 November 6, 1988. Regulation: 8.