510(k) K143213
- Device
- INOmax DSIR Plus MRI
- Applicant
- INO Therapeutics/Ikaria
- 510(k) number
- K143213
- Product code
- MRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-10
- Date received
- 2014-11-10
- Regulation
- 868.5165
- Classification name
- Apparatus, Nitric Oxide Delivery
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Robert Bovy
- Address
- 6603 Femrite Dr. Madison WI US 53718 53718
FDA Registration Numbers#
- 3006897516
- 3011193444
- 3004531588
- 2518435
- 2133810
- 1625392
- 3012160128
- 9611296
- 3012796317
- 3019771924
- 3014527933
Source Documents#
Other 510(k) Records For Product Code MRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | 2025-01-17 |
| K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2025-01-03 |
| K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | 2024-05-28 |
| K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2024-05-23 |
| K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2023-12-06 |
| K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2023-08-11 |
| K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | 2023-06-30 |
| K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | 2023-04-20 |
| K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2022-04-27 |
| K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | 2020-06-19 |
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020-06-17 |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | 2020-03-10 |
| K171696 | NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. | 2018-10-02 |
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics/Ikaria | 2013-11-29 |
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2013-05-02 |
Legacy Summary#
summary
FDA Review#
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