K200389 is an FDA 510(k) clearance for the INOmax DSIR Plus. This device is classified as a Apparatus, Nitric Oxide Delivery (Class II - Special Controls, product code MRN).
Submitted by Mallinckrodt Manufacturing, LLC (Madison, US). The FDA issued a Cleared decision on June 17, 2020, 120 days after receiving the submission on February 18, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K200389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2020 |
| Decision Date | June 17, 2020 |
| Days to Decision | 120 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MRN - Apparatus, Nitric Oxide Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5165 |