510(k) K043160 ยท JOH Tube Tracheostomy And Tube Cuff
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
| Applicant | Tracoe Medical GmbH, Westborough MA, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Nov 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043160
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.