SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 is an FDA 510(k)-cleared medical device (K011729) manufactured by Dni Nevada, 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 29, 2001. Regulation: 8.