510(k) K101034 ยท MXA System, Test, Breath Nitric Oxide
NIOX MINO MODEL 09-1000
| Applicant | Aerocrine AB, Solna, SE |
| Decision | Substantially Equivalent, Sep 2, 2010 |
| Received | Apr 14, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101034
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.