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FDA PRODUCT CODE · CLASS II

OLT — Non-Normalizing Quantitative Electroencephalograph Software

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a 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
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253767Universal Brain · 510k2026-06-30
K251881Hippoclinic · 510k2025-12-03
K251366Nihon Kohden Corporation · 510k2025-10-09

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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