510(k) K013728 ยท JOH Tube Tracheostomy And Tube Cuff
TRACH VOX
| Applicant | Engineered Medical Systems, Mccordsville IN, US |
| Decision | Substantially Equivalent, Jul 30, 2002 |
| Received | Nov 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013728
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.