510(k) K200389 ยท MRN Apparatus, Nitric Oxide Delivery
INOmax DSIR Plus
| Applicant | Mallinckrodt Manufacturing, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Jun 17, 2020 |
| Received | Feb 18, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200389
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.