510(k) K192000 ยท BWF Spirometer, Therapeutic (Incentive)
D R Burton OxyPAP
| Applicant | D R Burton Healthcare, LLC, Farmville NC, US |
| Decision | Substantially Equivalent, Feb 19, 2020 |
| Received | Jul 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192000
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.