510(k) K062104 ยท BTO Tube, Tracheostomy (W/Wo Connector)
TALKING TRACH
| Applicant | Engineered Medical Systems, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Apr 20, 2007 |
| Received | Jul 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062104
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.