Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip And Split Grid, Intraoperative Mapping Grid

Electrode, Cortical

Spes Medica SRL

The following data is part of a premarket notification filed by Spes Medica Srl with the FDA for Subdural Electrode, Strip/intraoperative Strip, Grid/intraoperative Grid, Multi-strip And Split Grid, Intraoperative Mapping Grid.

Pre-market Notification Details

Device IDK211954
510k NumberK211954
Device Name:Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip And Split Grid, Intraoperative Mapping Grid
ClassificationElectrode, Cortical
Applicant Spes Medica SRL Via Europa -Zona Industriale Battipaglia,  IT 84091
ContactGiorgio Facco
CorrespondentGiorgio Facco
Spes Medica SRL Via Europa - Zona Industriale Battipaglia,  IT 84091
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-23
Decision Date2022-11-10

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