510(k) K981080 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SCOOP 1
| Applicant | Transtracheal Systems, Boulder CO, US |
| Decision | Substantially Equivalent, Jun 17, 1998 |
| Received | Mar 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981080
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.