510(k) K222930 ยท MRN Apparatus, Nitric Oxide Delivery
Evolve Nitric Oxide Delivery System
| Applicant | Mallinckrodt Manufacturing, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Dec 6, 2023 |
| Received | Sep 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222930
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.