SD LTM STIM Cortical Stimulator

Electrode, Cortical

Micromed S.p.A.

The following data is part of a premarket notification filed by Micromed S.p.a. with the FDA for Sd Ltm Stim Cortical Stimulator.

Pre-market Notification Details

Device IDK180761
510k NumberK180761
Device Name:SD LTM STIM Cortical Stimulator
ClassificationElectrode, Cortical
Applicant micromed S.p.A. Via Giotto 2 Mogliano Veneto,  IT 31021
ContactMonica Camillo
CorrespondentJohn Ziobro
SpectraMedEx, LLC 3215 Golf Road, #149 Delafield,  WI  53018
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-23
Decision Date2018-06-18
Summary:summary

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