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FDA 510(k)

Disposable Non-invasive EEG Sensor

K-Number: K220448 · 2023-01-19

ApplicantShenzhen Med-Link Electronics Tech Co., Ltd.
Decision Date2023-01-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Non-invasive EEG Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K220448. 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 Non-invasive EEG Sensor?

Disposable Non-invasive EEG Sensor is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K220448.

When did Disposable Non-invasive EEG Sensor receive FDA 510(k) clearance?

Disposable Non-invasive EEG Sensor received FDA 510(k) clearance on 2023-01-19, under 510(k) number K220448.

Who is the listed applicant for Disposable Non-invasive EEG Sensor?

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

What is the FDA product code for Disposable Non-invasive EEG Sensor?

The FDA product code for Disposable Non-invasive EEG Sensor is GXY.

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Other records listing Shenzhen Med-Link Electronics Tech Co., Ltd. as applicant

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Official Source

View on FDA Database →

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