510(k) K192511 · BTO Tube, Tracheostomy (W/Wo Connector)
Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
| Applicant | Venner Medical (Singapore) Pte, Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Jul 22, 2020 |
| Received | Sep 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192511
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.