PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 is an FDA 510(k)-cleared medical device (K000206) manufactured by Axelgaard Mfg. Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 2000. Regulation: 8.