FDA 510(k)

Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

Número K: K251381 · 2025-10-31

Data da decisão2025-10-31

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K251381. 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 Ceribell Instant EEG Headcap (Small: C251, Medium: C252)?

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Ceribell, Inc.. The 510(k) number is K251381.

When did Ceribell Instant EEG Headcap (Small: C251, Medium: C252) receive FDA 510(k) clearance?

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) received FDA 510(k) clearance on 2025-10-31, under 510(k) number K251381.

Who is the listed applicant for Ceribell Instant EEG Headcap (Small: C251, Medium: C252)?

The FDA 510(k) record lists Ceribell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceribell Instant EEG Headcap (Small: C251, Medium: C252)?

The FDA product code for Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is GXY.

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K261712Ceribell EEG Analysis Software K261101Ceribell Monitor K260998Ceribell Neurology Review Software K260363Ceribell Brain Monitor Headband K254033Ceribell Instant EEG Headset K251936Ceribell Delirium Monitor System

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Fonte oficial

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