DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Nihon Kohden Corporation
Product code
Code OLT
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tokyo, JP
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OLT

product code OLT
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.