510(k) K203378 ยท BWF Spirometer, Therapeutic (Incentive)
Pulsehaler
| Applicant | Respinova, Ltd., Herzliya, IL |
| Decision | Substantially Equivalent, Mar 31, 2021 |
| Received | Nov 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203378
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.