510(k) K160116 ยท BZG Spirometer, Diagnostic
SpiroScout
| Applicant | Ganshorn Medizin Electronic GmbH, Niederlauer, DE |
| Decision | Substantially Equivalent, Oct 7, 2016 |
| Received | Jan 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160116
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.