K-number	K182874
Device name	Fenom Pro Nitric Oxide Test
Applicant	Spirosure, Inc.
Product code	MXA
Device class	Class II
Decision date	Feb 13, 2019
Decision	Substantially Equivalent
Regulation	862.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Fenom Pro Nitric Oxide Test

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