K-number	K240410
Device name	EVOLVE Nitric Oxide Delivery System
Applicant	Malinckrodt Manufacturing, LLC
Product code	MRN
Device class	Class II
Decision date	May 28, 2024
Decision	Substantially Equivalent
Regulation	868.5165

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View the full FDA submission: accessdata.fda.gov

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EVOLVE Nitric Oxide Delivery System

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