The following data is part of a premarket notification filed by Spes Medica S.r.l. with the FDA for Disposable Adhesive Surface Electrode.
| Device ID | K120494 |
| 510k Number | K120494 |
| Device Name: | DISPOSABLE ADHESIVE SURFACE ELECTRODE |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-17 |
| Decision Date | 2012-06-11 |
| Summary: | summary |