K-number	K123683
Device name	NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
Applicant	Aerocrine AB
Product code	MXA
Device class	Class II
Decision date	Dec 27, 2012
Decision	Substantially Equivalent
Regulation	862.3080

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Source

View the full FDA submission: accessdata.fda.gov

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NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

Everything you need for a 510(k) submission. Nothing you don't.