The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Sapphire Premiere.
| Device ID | K923303 |
| 510k Number | K923303 |
| Device Name: | SAPPHIRE PREMIERE |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | MEDELEC LTD. MANOR WAY OLD WOKING Surrey, England Gu22 9ju, GB |
| Contact | Holloway |
| Correspondent | Holloway MEDELEC LTD. MANOR WAY OLD WOKING Surrey, England Gu22 9ju, GB |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1992-11-24 |