INOmax DSIR Plus
K-Number: K200389 · 2020-06-17
ApplicantMallinckrodt Manufacturing, LLC
Decision Date2020-06-17
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
INOmax DSIR Plus is a medical device manufactured by Mallinckrodt Manufacturing, LLC. It received FDA 510(k) clearance on 2020-06-17 under approval number K200389. 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 Plus?
INOmax DSIR Plus is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Mallinckrodt Manufacturing, LLC. The 510(k) number is K200389.
When was INOmax DSIR Plus approved by the FDA?
INOmax DSIR Plus received FDA 510(k) clearance on 2020-06-17, under approval number K200389.
What company makes INOmax DSIR Plus?
INOmax DSIR Plus is manufactured by Mallinckrodt Manufacturing, LLC.
What is the FDA product code for INOmax DSIR Plus?
The FDA product code for INOmax DSIR Plus is MRN.
Other Devices by Mallinckrodt Manufacturing, LLC
Related Devices (Code: MRN)
K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.
K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc.
K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical
K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.
K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC
K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.
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.