FDA 510(k) Applications for Medical Device Product Code "MRN"
(Apparatus, Nitric Oxide Delivery)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K212409 | Airgas Therapeutics | Ulspira TS Nitric Oxide Therapy System | 06/30/2023 |
| K242374 | Airgas Therapeutics LLC | ULSPIRA TSÖ Nitric Oxide Therapy System | 01/17/2025 |
| K000186 | DATEX-OHMEDA | DATEX-OHMEDA INOVENT DELIVERY SYSTEM | 02/10/2000 |
| K120216 | GENO LLC | GENOSYL MV-1000 | 05/16/2012 |
| K061901 | INO THERAPEUTICS | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | 12/14/2006 |
| K093922 | INO THERAPEUTICS | INOMAX DS | 04/15/2010 |
| K121021 | INO THERAPEUTICS | INOMAX DS (DELIVERY SYSTEM) | 09/24/2012 |
| K080484 | INO THERAPEUTICS | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | 08/06/2008 |
| K110344 | INO THERAPEUTICS | INOMAX DSIR (DELIVERY SYSTEM) | 06/24/2011 |
| K130605 | INO THERAPEUTICS | INOMAX DSIR (DELIVERY SYSTEM) | 05/02/2013 |
| K071516 | INO THERAPEUTICS LLC | INOMAX DS | 10/03/2007 |
| K081691 | INO THERAPEUTICS LLC | INOMAX DS (DELIVERY SYSTEM) | 08/28/2008 |
| K092545 | INO THERAPEUTICS LLC | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | 03/10/2010 |
| K070867 | INO THERAPEUTICS LLC | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | 04/27/2007 |
| K113272 | INO THERAPEUTICS LLC/DBA IKARIA | INOMAX DS(DELIVERY SYSTEMS | 02/29/2012 |
| K110635 | INO THERAPEUTICS LLC/DBA IKARIA | INOMAX DS(IR) (DELIVERY SYSTEM) | 06/23/2011 |
| K131686 | INO THERAPEUTICS/IKARIA | INOMAX DSIR (DELIVERY SYSTEM) | 11/29/2013 |
| K143213 | INO Therapeutics/Ikaria | INOmax DSIR Plus MRI | 07/10/2015 |
| K193481 | International Biomedical | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | 03/10/2020 |
| K093260 | INTERNATIONAL BIOMEDICAL, LTD. | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM | 12/16/2009 |
| K220898 | Linde Gas & Equipment Inc. | NOxBOXi Nitric Oxide Delivery System | 04/27/2022 |
| K231823 | Linde Gas & Equipment Inc. | NOxBOXi Nitric Oxide Delivery System | 08/11/2023 |
| K233251 | Linde Gas & Equipment Inc. | NOxBOXi Nitric Oxide Delivery System | 05/23/2024 |
| K240410 | Malinckrodt Manufacturing LLC | EVOLVE Nitric Oxide Delivery System | 05/28/2024 |
| K222930 | Mallinckrodt Manufacturing LLC | Evolve Nitric Oxide Delivery System | 12/06/2023 |
| K242578 | Mallinckrodt Manufacturing LLC | EVOLVE Nitric Oxide Delivery System | 01/03/2025 |
| K211153 | Mallinckrodt Manufacturing LLC | Inomax DSIR | 04/20/2023 |
| K200389 | Mallinckrodt Manufacturing LLC | INOmax DSIR Plus | 06/17/2020 |
| DEN000001 | OHMEDA MEDICAL | OHMEDA INOVENT DELIVERY SYSTEM | 01/11/2000 |
| K171696 | Praxair Distribution, Inc | NOxBOXi Nitric Oxide Delivery System | 10/02/2018 |
| K201339 | Praxair, Inc. | The NOxBOXi Nitric Oxide Delivery System | 06/19/2020 |
| K000653 | PULMONOX MEDICAL CORP. | AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 | 08/04/2000 |
| K033779 | PULMONOX MEDICAL, INC. | VIANOX DELIVERY SYSTEM, MODEL II | 01/26/2004 |
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