510(k) K161676 · BZG Spirometer, Diagnostic
Q13 SPIROLYSER®
| Applicant | Fim Medical, Villeurbanne Cedex , Rhone, FR |
| Decision | Substantially Equivalent, Oct 20, 2016 |
| Received | Jun 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161676
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.