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FDA 510(k)

Ceribell Pocket EEG Device

K-Number: K191301 · 2019-09-11

ApplicantCeribell, Inc.
Decision Date2019-09-11
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Pocket EEG Device is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2019-09-11 under approval number K191301. 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 Pocket EEG Device?

Ceribell Pocket EEG Device is a medical device that received FDA 510(k) clearance on 2019-09-11. It is manufactured by Ceribell, Inc.. The 510(k) number is K191301.

When was Ceribell Pocket EEG Device approved by the FDA?

Ceribell Pocket EEG Device received FDA 510(k) clearance on 2019-09-11, under approval number K191301.

What company makes Ceribell Pocket EEG Device?

Ceribell Pocket EEG Device is manufactured by Ceribell, Inc..

What is the FDA product code for Ceribell Pocket EEG Device?

The FDA product code for Ceribell Pocket EEG Device is OMB.

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Other Devices by Ceribell, Inc.

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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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