BRAINSTREAM Disposable Deep Cup EEG Electrodes

Electrode, Cutaneous

CONMED Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Brainstream Disposable Deep Cup Eeg Electrodes.

Pre-market Notification Details

Device IDK200540
510k NumberK200540
Device Name:BRAINSTREAM Disposable Deep Cup EEG Electrodes
ClassificationElectrode, Cutaneous
Applicant CONMED Corporation 525 French Road Utica,  NY  13502
ContactTessa Hopsicker
CorrespondentTessa Hopsicker
CONMED Corporation 525 French Road Utica,  NY  13502
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-03
Decision Date2020-06-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986649 K200540 000
30653405986663 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986649 K200540 000
30653405986663 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000
30653405986649 K200540 000
30653405986656 K200540 000
30653405986663 K200540 000

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