The following data is part of a premarket notification filed by Spes Medica S.r.l. with the FDA for Laryngeal Surface Electrode.
| Device ID | K093373 |
| 510k Number | K093373 |
| Device Name: | LARYNGEAL SURFACE ELECTRODE |
| Classification | Stimulator, Nerve |
| Applicant | SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE Battipaglia, IT 84091 |
| Contact | Alfredo Spadavechia |
| Correspondent | Alfredo Spadavechia SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE Battipaglia, IT 84091 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2010-08-24 |
| Summary: | summary |