BABE-EASE NEONATAL CLOTH ECG ELECTRODE

BABE-EASE NEONATAL CLOTH ECG ELECTRODE is an FDA 510(k)-cleared medical device (K896844) manufactured by Labeltape Meditect, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 11, 1990. Regulation: 8.