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FDA PRODUCT CODE · CLASS II

OMB — Automatic Event Detection Software For Full-Montage Electroencephalograph

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1400
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K260998Ceribell, Inc. · 510k2026-06-24
K252070Ceribell, Inc. · 510k2025-11-21
K252160Persyst Development, LLC · 510k2025-10-31
K243743Holberg Eeg AS · 510k2025-04-09
K241589Ceribell, Inc. · 510k2025-04-09
K242446Persyst Development Corporation · 510k2025-01-22
K241390LVIS Corporation · 510k2024-11-26
K240408Epitel, Inc. · 510k2024-10-17

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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