510(k) K093922 ยท MRN Apparatus, Nitric Oxide Delivery
INOMAX DS
| Applicant | Ino Therapeutics, Madison WI, US |
| Decision | Substantially Equivalent, Apr 15, 2010 |
| Received | Dec 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093922
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2015 | INO Therapeutics (dba Ikaria) Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. Terminated |
MRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.