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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 a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2025-04-09 under approval 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. It is manufactured by Ceribell, Inc.. The 510(k) number is K241589.

When was Ceribell Seizure Detection Software approved by the FDA?

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

What company makes Ceribell Seizure Detection Software?

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

What is the FDA product code for Ceribell Seizure Detection Software?

The FDA product code for Ceribell 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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