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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 the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2019-09-11 under 510(k) 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. The listed applicant is Ceribell, Inc.. The 510(k) number is K191301.

When did Ceribell Pocket EEG Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Ceribell Pocket EEG Device?

The FDA 510(k) record lists Ceribell, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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NCT07485244EEG Abnormalities in Adult ICU Patients With High Risk of DeliriumRECRUITINGNCT07449416Ceribell Delirium Monitor Outcomes Pilot StudyRECRUITING

Other records listing Ceribell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261101Ceribell MonitorK260998Ceribell Neurology Review SoftwareK260363Ceribell Brain Monitor HeadbandK254033Ceribell Instant EEG HeadsetK251936Ceribell Delirium Monitor SystemK252070Ceribell Infant Seizure Detection Software

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Related Devices (Code: OMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE (V 2.0.0)Holberg Eeg ASK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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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