BARD(R) BIOPOTENTIAL AMPLIFIER II

BARD(R) BIOPOTENTIAL AMPLIFIER II is an FDA 510(k)-cleared medical device (K913875) manufactured by Bard Electrophysiology. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 1991. Regulation: 8.