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FDA 510(k)

Ceribell Seizure Detection Software

K-Number: K241589 · 2025-04-09

ApplicantCeribell, Inc.
Decision Date2025-04-09
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell 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 2025-04-09 under 510(k) number K241589. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceribell Seizure Detection Software?

Ceribell Seizure Detection Software is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Ceribell, Inc.. The 510(k) number is K241589.

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

Ceribell Seizure Detection Software received FDA 510(k) clearance on 2025-04-09, under 510(k) number K241589.

Who is the listed applicant for Ceribell 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 Seizure Detection Software?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07449416Ceribell Delirium Monitor Outcomes Pilot StudyRECRUITING

Other records listing Ceribell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261101Ceribell MonitorK260998Ceribell Neurology Review SoftwareK260363Ceribell Brain Monitor HeadbandK254033Ceribell Instant EEG HeadsetK251936Ceribell Delirium Monitor SystemK252070Ceribell Infant Seizure Detection Software

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Related Devices (Code: OMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE (V 2.0.0)Holberg Eeg ASK242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development CorporationK241390NeuroMatchLVIS Corporation

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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