BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR

BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR is an FDA 510(k)-cleared medical device (K020739) manufactured by Bci, 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 June 2, 2002. Regulation: 8.