G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE

G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE is an FDA 510(k)-cleared medical device (K955815) manufactured by Cmc Sense-It, 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 July 22, 1996. Regulation: 8.