510(k) K003745 ยท ETN Stimulator, Nerve
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
| Applicant | Rln Systems, Inc., Jefferson City MO, US |
| Decision | Substantially Equivalent, Jan 16, 2001 |
| Received | Dec 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2010 | Neurovision Medical Products Inc 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL)
For use as a Surgical stimulator/locator for recurrent laryngeal nerve. Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.