Puffin Lite Infant Resuscitation System

Puffin Lite Infant Resuscitation System is an FDA 510(k)-cleared medical device (K182956) manufactured by International Biomedical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 2019. Regulation: 8.