Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Amydi-med Disposable Non-invasive EEG electrodes

K-Number: K240668 · 2024-03-19

ApplicantShenzhen Amydi-Med Electrics Tech Co., Ltd.
Decision Date2024-03-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Amydi-med Disposable Non-invasive EEG electrodes is a medical device manufactured by Shenzhen Amydi-Med Electrics Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under approval number K240668. 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 Amydi-med Disposable Non-invasive EEG electrodes?

Amydi-med Disposable Non-invasive EEG electrodes is a medical device that received FDA 510(k) clearance on 2024-03-19. It is manufactured by Shenzhen Amydi-Med Electrics Tech Co., Ltd.. The 510(k) number is K240668.

When was Amydi-med Disposable Non-invasive EEG electrodes approved by the FDA?

Amydi-med Disposable Non-invasive EEG electrodes received FDA 510(k) clearance on 2024-03-19, under approval number K240668.

What company makes Amydi-med Disposable Non-invasive EEG electrodes?

Amydi-med Disposable Non-invasive EEG electrodes is manufactured by Shenzhen Amydi-Med Electrics Tech Co., Ltd..

What is the FDA product code for Amydi-med Disposable Non-invasive EEG electrodes?

The FDA product code for Amydi-med Disposable Non-invasive EEG electrodes is GXY.

Related Clinical Trials

NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07226011 Accelerated High-Dose tDCS for Depression RECRUITING NCT07580066 Cerebellum and Neglect NOT_YET_RECRUITING NCT07578324 TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial NOT_YET_RECRUITING NCT02875964 Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings. COMPLETED NCT04782869 Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy COMPLETED

Related Devices (Code: GXY)

K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2WMedico Electrodes International , Ltd. K160081TENS ElectrodesCathay Manufacturing Corp. K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc. K152815Mailuokang Self-adhesive ElectrodeShenzhen Mailuokang Technology Co., Ltd. K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd

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.

↑