510(k) K211153 ยท MRN Apparatus, Nitric Oxide Delivery
Inomax DSIR
| Applicant | Mallinckrodt Manufacturing, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Apr 20, 2023 |
| Received | Apr 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211153
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.