510(k) K083617 ยท MXA System, Test, Breath Nitric Oxide
APIERON INSIGHT ENO SYSTEM
| Applicant | Apieron, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Jan 27, 2009 |
| Received | Dec 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083617
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.