510(k) K223542 ยท PNZ Eustachian Tube Balloon Dilation Device
TubaVent Balloon Dilatation System
| Applicant | Spiggle & Theis Medizintechnik GmbH, Overath, DE |
| Decision | Substantially Equivalent, Aug 3, 2023 |
| Received | Nov 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223542
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.