FDA 510(k)

Ceribell Infant Seizure Detection Software

Número K: K252070 · 2025-11-21

Data da decisão2025-11-21

Código do produtoOMB

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ceribell Infant Seizure Detection Software is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K252070. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ceribell Infant Seizure Detection Software?

Ceribell Infant Seizure Detection Software is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Ceribell, Inc.. The 510(k) number is K252070.

When did Ceribell Infant Seizure Detection Software receive FDA 510(k) clearance?

Ceribell Infant Seizure Detection Software received FDA 510(k) clearance on 2025-11-21, under 510(k) number K252070.

Who is the listed applicant for Ceribell Infant Seizure Detection Software?

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 Infant Seizure Detection Software?

The FDA product code for Ceribell Infant Seizure Detection Software is OMB.

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Outros registros que listam Ceribell, Inc. como candidato(a)

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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Dispositivos Relacionados (Código: OMB)

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLC K243743autoSCORE (V 2.0.0)Holberg Eeg AS K241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation K241390NeuroMatchLVIS Corporation

Fonte oficial

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