Disposable Gold Cup EEG Electrodes
K-Number: K192564 · 2020-01-21
ApplicantDymedix Diagnostics, Inc.
Decision Date2020-01-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Disposable Gold Cup EEG Electrodes is a medical device manufactured by Dymedix Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-01-21 under approval number K192564. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Gold Cup EEG Electrodes?
Disposable Gold Cup EEG Electrodes is a medical device that received FDA 510(k) clearance on 2020-01-21. It is manufactured by Dymedix Diagnostics, Inc.. The 510(k) number is K192564.
When was Disposable Gold Cup EEG Electrodes approved by the FDA?
Disposable Gold Cup EEG Electrodes received FDA 510(k) clearance on 2020-01-21, under approval number K192564.
What company makes Disposable Gold Cup EEG Electrodes?
Disposable Gold Cup EEG Electrodes is manufactured by Dymedix Diagnostics, Inc..
What is the FDA product code for Disposable Gold Cup EEG Electrodes?
The FDA product code for Disposable Gold Cup EEG Electrodes is GXY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.