Inomax DSIR
K-Number: K211153 · 2023-04-20
ApplicantMallinckrodt Manufacturing, LLC
Decision Date2023-04-20
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Inomax DSIR is a medical device manufactured by Mallinckrodt Manufacturing, LLC. It received FDA 510(k) clearance on 2023-04-20 under approval number K211153. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Inomax DSIR?
Inomax DSIR is a medical device that received FDA 510(k) clearance on 2023-04-20. It is manufactured by Mallinckrodt Manufacturing, LLC. The 510(k) number is K211153.
When was Inomax DSIR approved by the FDA?
Inomax DSIR received FDA 510(k) clearance on 2023-04-20, under approval number K211153.
What company makes Inomax DSIR?
Inomax DSIR is manufactured by Mallinckrodt Manufacturing, LLC.
What is the FDA product code for Inomax DSIR?
The FDA product code for Inomax DSIR is MRN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.