K-number	K131562
Device name	BREATHE NIOV VENTILATION SYSTEM
Applicant	Breathe Technologies
Product code	ONZ
Device class	Class II
Decision date	Mar 6, 2014
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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BREATHE NIOV VENTILATION SYSTEM

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