Disposable Gold Cup EEG Electrodes

Electrode, Cutaneous

Dymedix Diagnostics, Inc.

The following data is part of a premarket notification filed by Dymedix Diagnostics, Inc. with the FDA for Disposable Gold Cup Eeg Electrodes.

Pre-market Notification Details

Device IDK192564
510k NumberK192564
Device Name:Disposable Gold Cup EEG Electrodes
ClassificationElectrode, Cutaneous
Applicant Dymedix Diagnostics, Inc. 5985 Rice Creek Parkway Shoreview,  MN  55126
ContactTodd Eiken
CorrespondentTodd Eiken
Dymedix Diagnostics, Inc. 5985 Rice Creek Parkway Shoreview,  MN  55126
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-18
Decision Date2020-01-21

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