510(k) K163091 ยท BWF Spirometer, Therapeutic (Incentive)
VibraPEP
| Applicant | Medica Holdings, LLC, Lake Oswego OR, US |
| Decision | Substantially Equivalent, Feb 21, 2017 |
| Received | Nov 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163091
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.