The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Sapphire 4me Emg/ep System.
| Device ID | K912775 |
| 510k Number | K912775 |
| Device Name: | SAPPHIRE 4ME EMG/EP SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Contact | J. B Holloway |
| Correspondent | J. B Holloway MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1991-11-08 |