Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip And Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

Electrode, Cortical

Ad-Tech Medical Instrument Corporation

The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for Subdural Strip/intraoperative Split Electrode, Subdural Grid/intraoperative Grid Electrode, Dual-sided Interhemispheric Subdural Electrode, Multi-strip And Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode.

Pre-market Notification Details

Device IDK191186
510k NumberK191186
Device Name:Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip And Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
ClassificationElectrode, Cortical
Applicant Ad-Tech Medical Instrument Corporation 400 West Oakview Parkway Oak Creek,  WI  53154
ContactLisa Theama
CorrespondentGary J Syring
QUALITY & REGULATORY ASSOCIATES, LLC. 800 LEVANGER LANE Stoughton,  WI  53589
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-03
Decision Date2020-01-25

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