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 |