510(k) K181660 ยท BWF Spirometer, Therapeutic (Incentive)
Acapella Choice Blue Vibratory PEP Device
| Applicant | Smiths Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 24, 2019 |
| Received | Jun 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181660
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.