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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 the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2023-05-23 under 510(k) 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. The listed applicant is Ceribell, Inc.. The 510(k) number is K223504.

When did Ceribell Status Epilepticus Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Ceribell Status Epilepticus Monitor?

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 Status Epilepticus Monitor?

The FDA product code for Ceribell Status Epilepticus Monitor is OMB.

Related Clinical Trials

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.

NCT07449416Ceribell 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.

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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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