K-number	K211153
Device name	Inomax DSIR
Applicant	Mallinckrodt Manufacturing, LLC
Product code	MRN
Device class	Class II
Decision date	Apr 20, 2023
Decision	Substantially Equivalent
Regulation	868.5165

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Source

View the full FDA submission: accessdata.fda.gov

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Inomax DSIR

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