K211153 is an FDA 510(k) clearance for the Inomax DSIR. 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 April 20, 2023, 731 days after receiving the submission on April 19, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K211153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | April 20, 2023 |
| Days to Decision | 731 days |
| Submission Type | Traditional |
| 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 |