510(k) K242578 ยท MRN Apparatus, Nitric Oxide Delivery
EVOLVE Nitric Oxide Delivery System
| Applicant | Mallinckrodt Manufacturing, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Jan 3, 2025 |
| Received | Aug 29, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242578
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.