K-number	K110635
Device name	INOMAX DS(IR) (DELIVERY SYSTEM)
Applicant	Ino Therapeutics, LLC/Dba Ikaria
Product code	MRN
Device class	Class II
Decision date	Jun 23, 2011
Decision	Substantially Equivalent
Regulation	868.5165

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View the full FDA submission: accessdata.fda.gov

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INOMAX DS(IR) (DELIVERY SYSTEM)

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