CAMBRIDGE HEART HI-RES ECG ELECTRODE

CAMBRIDGE HEART HI-RES ECG ELECTRODE is an FDA 510(k)-cleared medical device (K962115) manufactured by Cambridge Heart, 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 28, 1996. Regulation: 8.