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Ceribell, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories4
Latest FDA decision2026-06-30

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-10). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K261101 Ceribell MonitorOMC2026-06-30 View
510(k) K260998 Ceribell Neurology Review SoftwareOMB2026-06-24 View
510(k) K260363 Ceribell Brain Monitor HeadbandGXY2026-04-03 View
510(k) K254033 Ceribell Instant EEG HeadsetGXY2026-02-09 View
510(k) K251936 Ceribell Delirium Monitor SystemNCG2025-12-08 View
510(k) K252070 Ceribell Infant Seizure Detection SoftwareOMB2025-11-21 View
510(k) K251381 Ceribell Instant EEG Headcap (Small: C251, Medium: C252)GXY2025-10-31 View
510(k) K241589 Ceribell Seizure Detection SoftwareOMB2025-04-09 View
510(k) K232052 Ceribell Instant EEG HeadbandGXY2023-08-08 View
510(k) K223504 Ceribell Status Epilepticus MonitorOMB2023-05-23 View
510(k) K223086 Ceribell Instant EEG HeadcapGXY2023-03-22 View
510(k) K210805 Ceribell Instant EEG HeadbandGXY2021-08-30 View
510(k) K191301 Ceribell Pocket EEG DeviceOMB2019-09-11 View
510(k) K171459 Ceribell Instant EEG HeadbandGXY2017-08-21 View
510(k) K170363 Ceribell Pocket EEG DeviceOMC2017-05-08 View

Related Clinical Trials

NCT07449416Ceribell Delirium Monitor Outcomes Pilot StudyRECRUITINGNCT07485244EEG Abnormalities in Adult ICU Patients With High Risk of DeliriumRECRUITING
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