CERIBELL, INC.

FDA Device Registration & Listing · Sunnyvale, CA, US · Registration 3013671918

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013671918
FEI Number
3013671918
Entity Name
CERIBELL, INC.
City/State/Country
Sunnyvale, CA, US
Establishment Address
360 N Pastoria Ave, Sunnyvale, CA 94085, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ceribell, Inc. (Owner Number: 10055114)
Owner / Operator Contact Address
360 N Pastoria Ave, Sunnyvale, CA 94085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170363
PMA Number
N/A

All Registered Proprietary Names

Ceribell EEG Headband Ceribell Infant Seizure Detection Software (Clarity) Ceribell Instant EEG Headcap ClarityPro Ceribell Instant EEG Headset Ceribell Seizure Detection Software (Clarity) Ceribell Delirium Monitor System Ceribell EEG Recorder with Clarity Ceribell Brain Monitor Headband Ceribell EEG Recorder

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-11-22
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-11-22
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2026-04-16
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-04-16
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2023-11-07
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-04-16
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2026-04-16
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2026-04-16
NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid Neurology Class 2 882.1440 2026-04-16
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2026-04-16
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2020-11-30
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2020-11-30
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2020-11-30
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-04-16
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2017-06-08
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2017-06-08

Official Correspondent

Raymond Woo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ceribell, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2008 Bio-Logic Systems Corp 2
Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013671918. Last updated year: 2026. Please use registration number 3013671918 when referencing this establishment in official correspondence.
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