510(k) K223629 ยท BTY Calculator, Predicted Values, Pulmonary Function
SpiroSphere, SpiroSphereECG, CardioSphere
| Applicant | Eresearchtechnology GmbH, Estenfeld, DE |
| Decision | Substantially Equivalent, May 28, 2024 |
| Received | Dec 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223629
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.