BIO-SENSOR 01 EKG ELECTRODE

BIO-SENSOR 01 EKG ELECTRODE is an FDA 510(k)-cleared medical device (K911472) manufactured by Bio-Sensor, 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 October 9, 1991. Regulation: 8.