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FDA 510(k)

BRAINSTREAM Disposable Deep Cup EEG Electrodes

K-Number: K200540 · 2020-06-01

ApplicantConmed Corporation
Decision Date2020-06-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINSTREAM Disposable Deep Cup EEG Electrodes is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2020-06-01 under approval number K200540. 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 BRAINSTREAM Disposable Deep Cup EEG Electrodes?

BRAINSTREAM Disposable Deep Cup EEG Electrodes is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by Conmed Corporation. The 510(k) number is K200540.

When was BRAINSTREAM Disposable Deep Cup EEG Electrodes approved by the FDA?

BRAINSTREAM Disposable Deep Cup EEG Electrodes received FDA 510(k) clearance on 2020-06-01, under approval number K200540.

What company makes BRAINSTREAM Disposable Deep Cup EEG Electrodes?

BRAINSTREAM Disposable Deep Cup EEG Electrodes is manufactured by Conmed Corporation.

What is the FDA product code for BRAINSTREAM Disposable Deep Cup EEG Electrodes?

The FDA product code for BRAINSTREAM Disposable Deep 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.

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