The following data is part of a premarket notification filed by Micromed S.p.a. with the FDA for Sd Ltm Stim Cortical Stimulator.
| Device ID | K180761 |
| 510k Number | K180761 |
| Device Name: | SD LTM STIM Cortical Stimulator |
| Classification | Electrode, Cortical |
| Applicant | micromed S.p.A. Via Giotto 2 Mogliano Veneto, IT 31021 |
| Contact | Monica Camillo |
| Correspondent | John Ziobro SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-06-18 |
| Summary: | summary |