www.fdanews.com/articles/122637-fda-clears-nasal-aire-ii-petite-mask-for-pediatric-use
FDA Clears Nasal-Aire II Petite Mask for Pediatric Use
December 3, 2009
The US Food and Drug Administration granted 510(k) clearance to the Nasal Aire II Petite mask for CPAP use in children the age of 7 years and older or weighing more than 40 lbs.
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