BABI PLUS INFANT NASAL CANNULA SYSTEM

BABI PLUS INFANT NASAL CANNULA SYSTEM is an FDA 510(k)-cleared medical device (K093716) manufactured by A Plus Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2010. Regulation: 8.