510(k) K143213 ยท MRN Apparatus, Nitric Oxide Delivery
INOmax DSIR Plus MRI
| Applicant | Ino Therapeutics/Ikaria, Madison WI, US |
| Decision | Substantially Equivalent, Jul 10, 2015 |
| Received | Nov 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143213
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.