FDA 510(k)

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

Numéro K : K251366 · 2025-10-09

Date de décision2025-10-09

Code produitOLT

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K251366.

When did EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) receive FDA 510(k) clearance?

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 510(k) number K251366.

Who is the listed applicant for EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Source officielle

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