510(k) K110635 ยท MRN Apparatus, Nitric Oxide Delivery
INOMAX DS(IR) (DELIVERY SYSTEM)
| Applicant | Ino Therapeutics, LLC/Dba Ikaria, Port Allen LA, US |
| Decision | Substantially Equivalent, Jun 23, 2011 |
| Received | Mar 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110635
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.