GEREONICS BIOPOTENTIAL SKIN ELECTRODES

GEREONICS BIOPOTENTIAL SKIN ELECTRODES is an FDA 510(k)-cleared medical device (K861099) manufactured by Gereonics, 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 5, 1986. Regulation: 8.