| K-number | K912775 |
| Device name | SAPPHIRE 4ME EMG/EP SYSTEM |
| Applicant | Medelec Intl. Corp. |
| Product code | GWF |
| Device class | Class II |
| Decision date | Nov 8, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 882.1870 |
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