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FDA 510(k)

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

K-Number: K200162 · 2020-04-21

ApplicantWuhan Greentek Pty , Ltd.
Decision Date2020-04-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is a medical device manufactured by Wuhan Greentek Pty , Ltd.. It received FDA 510(k) clearance on 2020-04-21 under approval number K200162. 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 EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is a medical device that received FDA 510(k) clearance on 2020-04-21. It is manufactured by Wuhan Greentek Pty , Ltd.. The 510(k) number is K200162.

When was Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) approved by the FDA?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) received FDA 510(k) clearance on 2020-04-21, under approval number K200162.

What company makes Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is manufactured by Wuhan Greentek Pty , Ltd..

What is the FDA product code for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

The FDA product code for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is GXY.

Related Clinical Trials

NCT02875964 Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings. COMPLETED NCT06155695 Auditory Control Enhancement (ACE) in Schizophrenia TERMINATED

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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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