SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE

SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE is an FDA 510(k)-cleared medical device (K955800) 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 May 16, 1996. Regulation: 8.