K-number	K101034
Device name	NIOX MINO MODEL 09-1000
Applicant	Aerocrine AB
Product code	MXA
Device class	Class II
Decision date	Sep 2, 2010
Decision	Substantially Equivalent
Regulation	862.3080

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View the full FDA submission: accessdata.fda.gov

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NIOX MINO MODEL 09-1000

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