510(k) K093373 ยท ETN Stimulator, Nerve
LARYNGEAL SURFACE ELECTRODE
| Applicant | Spes Medica Srl, Battipaglia, IT |
| Decision | Substantially Equivalent, Aug 24, 2010 |
| Received | Oct 29, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2021 | Spes Medica Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures. Terminated |
ETN | None listed |
| Apr 8, 2021 | Spes Medica Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures. Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.