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FDA 510(k)

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

K-Number: K251366 · 2025-10-09

ApplicantNihon Kohden Corporation
Decision Date2025-10-09
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) is a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2025-10-09 under approval number K251366. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)?

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) is a medical device that received FDA 510(k) clearance on 2025-10-09. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K251366.

When was EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) approved by the FDA?

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) received FDA 510(k) clearance on 2025-10-09, under approval number K251366.

What company makes EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)?

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) is manufactured by Nihon Kohden Corporation.

What is the FDA product code for EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)?

The FDA product code for EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) is OLT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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