MEDI-TRACE 4103 NEONATAL ELECTRODE

MEDI-TRACE 4103 NEONATAL ELECTRODE is an FDA 510(k)-cleared medical device (K981964) manufactured by Graphic Controls Corp.. 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 12, 1998. Regulation: 8.