510(k) K221058 ยท BWF Spirometer, Therapeutic (Incentive)
LungTrainer (MD2 & MD3)
| Applicant | Lung Trainers, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Jul 5, 2023 |
| Received | Apr 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221058
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.