510(k) K183108 ยท BWF Spirometer, Therapeutic (Incentive)
Combined Aerobika OPEP and VersaPAP device
| Applicant | Trudell Medical International, London, CA |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Nov 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183108
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.