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FDA 510(k)

Ceribell Infant Seizure Detection Software

K-Number: K252070 · 2025-11-21

ApplicantCeribell, Inc.
Decision Date2025-11-21
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Infant Seizure Detection Software is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2025-11-21 under approval number K252070. 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 Infant Seizure Detection Software?

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

When was Ceribell Infant Seizure Detection Software approved by the FDA?

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

What company makes Ceribell Infant Seizure Detection Software?

Ceribell Infant Seizure Detection Software is manufactured by Ceribell, Inc..

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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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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