FDAnews
www.fdanews.com/articles/150510-medtronic-gains-fda-clearance-for-new-pediatric-oxygenation-system-for-neonate

Medtronic Gains FDA Clearance for New Pediatric Oxygenation System for Neonate

October 26, 2012
Medtronic announced FDA 510(k) clearance and the first U.S. clinical use of its new Affinity Pixie Oxygenation System.
Benzinga