510(k) K081691 ยท MRN Apparatus, Nitric Oxide Delivery
INOMAX DS (DELIVERY SYSTEM)
| Applicant | Ino Therapeutics, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Aug 28, 2008 |
| Received | Jun 17, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081691
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.