EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)— 510(k) K251366

Substantially Equivalent

Nihon Kohden Corporation

FDA 510(k) clearance K251366 for EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A), Substantially Equivalent on 2025-10-09. Applicant: Nihon Kohden Corporation.

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code OLT
Advisory panel: Neurology
Date received: 2025-05-01
Decision date: 2025-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.