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FDA 510(k)

Ceribell Status Epilepticus Monitor

K-Number: K223504 · 2023-05-23

ApplicantCeribell, Inc.
Decision Date2023-05-23
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Status Epilepticus Monitor is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2023-05-23 under approval number K223504. 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 Status Epilepticus Monitor?

Ceribell Status Epilepticus Monitor is a medical device that received FDA 510(k) clearance on 2023-05-23. It is manufactured by Ceribell, Inc.. The 510(k) number is K223504.

When was Ceribell Status Epilepticus Monitor approved by the FDA?

Ceribell Status Epilepticus Monitor received FDA 510(k) clearance on 2023-05-23, under approval number K223504.

What company makes Ceribell Status Epilepticus Monitor?

Ceribell Status Epilepticus Monitor is manufactured by Ceribell, Inc..

What is the FDA product code for Ceribell Status Epilepticus Monitor?

The FDA product code for Ceribell Status Epilepticus Monitor 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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