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FDA 510(k)

Ceribell Pocket EEG Device

K-Number: K170363 · 2017-05-08

ApplicantCeribell, Inc.
Decision Date2017-05-08
Product CodeOMC
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 2017-05-08 under approval number K170363. The device is classified under product code OMC. 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 2017-05-08. It is manufactured by Ceribell, Inc.. The 510(k) number is K170363.

When was Ceribell Pocket EEG Device approved by the FDA?

Ceribell Pocket EEG Device received FDA 510(k) clearance on 2017-05-08, under approval number K170363.

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 OMC.

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Other Devices by Ceribell, Inc.

K171459Ceribell Instant EEG Headband K191301Ceribell Pocket EEG Device K210805Ceribell Instant EEG Headband K232052Ceribell Instant EEG Headband K223504Ceribell Status Epilepticus Monitor K223086Ceribell Instant EEG Headcap

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Related Devices (Code: OMC)

K183529AE-120A EEG Head SetNihon Kohden Corporation K192549Byteflies KitByteflies NV K203827REMIEpitel, Inc. K221563Neurosteer EEG RecorderNeurosteer, Inc. K230933REMI Remote EEG Monitoring SystemEpitel, Inc. K223628NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC

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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