510(k) K221030 ยท BTY Calculator, Predicted Values, Pulmonary Function
Model 9100 PFT/DICO
| Applicant | Vitalograph Ireland, Ltd., Ennis Co Clare, IE |
| Decision | Substantially Equivalent, Jul 15, 2022 |
| Received | Apr 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221030
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.