K912775 is an FDA 510(k) clearance for the SAPPHIRE 4ME EMG/EP SYSTEM. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Medelec Intl. Corp. (England, GB). The FDA issued a Cleared decision on November 8, 1991, 137 days after receiving the submission on June 24, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K912775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1991 |
| Decision Date | November 08, 1991 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |