510(k) K182847 ยท BWF Spirometer, Therapeutic (Incentive)
Hudson RCI Voldyne Volumetric Exerciser
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Jul 1, 2019 |
| Received | Oct 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182847
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.