510(k) K173937 ยท BTY Calculator, Predicted Values, Pulmonary Function
SpiroSphere
| Applicant | Eresearchtechnology GmbH, Estenfeld, DE |
| Decision | Substantially Equivalent, Feb 15, 2019 |
| Received | Dec 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173937
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.