K-number	K212409
Device name	Ulspira TS Nitric Oxide Therapy System
Applicant	Airgas Therapeutics
Product code	MRN
Device class	Class II
Decision date	Jun 30, 2023
Decision	Substantially Equivalent
Regulation	868.5165

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View the full FDA submission: accessdata.fda.gov

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Ulspira TS Nitric Oxide Therapy System

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