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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Amydi-Med Electrics Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) 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. The listed applicant is Shenzhen Amydi-Med Electrics Tech Co., Ltd.. The 510(k) number is K240668.

When did Amydi-med Disposable Non-invasive EEG electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Amydi-med Disposable Non-invasive EEG electrodes?

The FDA 510(k) record lists Shenzhen Amydi-Med Electrics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Official Source

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