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510(k) K200389

Device
INOmax DSIR Plus
Applicant
Mallinckrodt Manufacturing LLC
510(k) number
K200389
Product code
MRN  
Decision
Substantially Equivalent (SESE)
Decision date
2020-06-17
Date received
2020-02-18
Regulation
868.5165
Classification name
Apparatus, Nitric Oxide Delivery
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David Trueblood
Address
6603 Femrite Dr. Madison WI US 53718 53718

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC2025-01-17
K242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC2025-01-03
K240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC2024-05-28
K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.2024-05-23
K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC2023-12-06
K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.2023-08-11
K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics2023-06-30
K211153Inomax DSIRMallinckrodt Manufacturing, LLC2023-04-20
K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.2022-04-27
K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc.2020-06-19
K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical2020-03-10
K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.2018-10-02
K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria2015-07-10
K131686INOMAX DSIR (DELIVERY SYSTEM)Ino Therapeutics/Ikaria2013-11-29
K130605INOMAX DSIR (DELIVERY SYSTEM)Ino Therapeutics2013-05-02

Legacy Summary#

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FDA Review#

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