510(k) K190853 ยท BZC Calculator, Pulmonary Function Data
Vyntus BODY
| Applicant | Vyaire Medical, Inc., Mettawa IL, US |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Apr 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190853
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.