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FDA 510(k)

Disposable EEG cable

K-Number: K213884 · 2022-05-06

ApplicantShenzhen Changke Connect Electronics Co., Ltd.
Decision Date2022-05-06
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable EEG cable is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K213884. 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 cable?

Disposable EEG cable is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K213884.

When did Disposable EEG cable receive FDA 510(k) clearance?

Disposable EEG cable received FDA 510(k) clearance on 2022-05-06, under 510(k) number K213884.

Who is the listed applicant for Disposable EEG cable?

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

What is the FDA product code for Disposable EEG cable?

The FDA product code for Disposable EEG cable is GXY.

Other records listing Shenzhen Changke Connect Electronics Co., Ltd. as applicant

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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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