NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)

NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) is an FDA 510(k)-cleared medical device (K872871) manufactured by Labeltape Meditect, 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 October 15, 1987. Regulation: 8.