Medical Device Manufacturer · US , Sunnyvale , CA

Ceribell, Inc.

12 submissions · 12 cleared · Since 2017
12
Total
12
Cleared
0
Denied

Ceribell, Inc. — FDA 510(k) Submissions

Ceribell, Inc. has submitted 12 FDA 510(k) premarket notifications since 2017, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Cutaneous, Automatic Event Detection Software For Full-montage Electroencephalograph, Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, Reduced- Montage Standard Electroencephalograph . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Ceribell Instant EEG Headset
K254033 · GXY Electrode, Cutaneous · Neurology
Feb 2026 55d
Ceribell Delirium Monitor System
K251936 · NCG Neuropsychiatric... · Neurology
Dec 2025 167d
Ceribell Infant Seizure Detection Software
K252070 · OMB Automatic Event Detection... · Neurology
Nov 2025 143d
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · GXY Electrode, Cutaneous · Neurology
Oct 2025 182d
Ceribell Seizure Detection Software
K241589 · OMB Automatic Event Detection... · Neurology
Apr 2025 310d
Ceribell Instant EEG Headband
K232052 · GXY Electrode, Cutaneous · Neurology
Aug 2023 29d
Ceribell Status Epilepticus Monitor
K223504 · OMB Automatic Event Detection... · Neurology
May 2023 182d
Ceribell Instant EEG Headcap
K223086 · GXY Electrode, Cutaneous · Neurology
Mar 2023 173d
Ceribell Instant EEG Headband
K210805 · GXY Electrode, Cutaneous · Neurology
Aug 2021 166d
Ceribell Pocket EEG Device
K191301 · OMB Automatic Event Detection... · Neurology
Sep 2019 120d
Ceribell Instant EEG Headband
K171459 · GXY Electrode, Cutaneous · Neurology
Aug 2017 95d
Ceribell Pocket EEG Device
K170363 · OMC Reduced- Montage Standard... · Neurology
May 2017 91d
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