The following data is part of a premarket notification filed by Sanibel Supply with the FDA for Disposable Electrode.
| Device ID | K111737 |
| 510k Number | K111737 |
| Device Name: | DISPOSABLE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | SANIBEL SUPPLY DREJERVAENGET 8 Assens, DK Dk-5610 |
| Contact | Erik Nielsen |
| Correspondent | Erik Nielsen SANIBEL SUPPLY DREJERVAENGET 8 Assens, DK Dk-5610 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-21 |
| Decision Date | 2011-10-14 |