K180761 is an FDA 510(k) clearance for the SD LTM STIM Cortical Stimulator. This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on June 18, 2018, 87 days after receiving the submission on March 23, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K180761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2018 |
| Decision Date | June 18, 2018 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYC - Electrode, Cortical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1310 |