June 4, 2014 | Austin, Texas US – International Biomedical®, a leader in infant care products, has obtained a 510(k) regulatory clearance from U.S. Food and Drug Administration (FDA) for their Puffin™ Infant Resuscitator. The clearance adds to the company’s growing and diverse line of products.
Almost 15% of all neonates are in need of respiratory support at birth. For those affected newborns, the Puffin™ offers everything needed at their bedside: T-Piece or bag and mask ventilation, integrated suction which makes airway management less stressful and blended air/oxygen delivery along with monitored delivery of positive pressure breaths.
Download Press Release: Press Release – 510K Regulatory Clearance from U.S. FDA for Puffin™ Infant Resuscitator