FDA 510(k)

Disposable Non-invasive EEG Sensor

Número K: K220448 · 2023-01-19

RequerenteShenzhen Med-Link Electronics Tech Co., Ltd.

Data da decisão2023-01-19

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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