# K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Aug 29, 2008 after 183 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944678 (1995). 2 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992742: Neurofax, Model Eeg-1100A, Nihon Kohden America, Inc. (1999) Summary page 1.

## Most influential descendants
- K120888: PSG-1100 Sleep Diagnostic System (2012), 6 descendants of its own
- K142774: Polysmith Sleep System (2015), 4 descendants of its own
- K113117: Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box (2012), 2 descendants of its own
- K173868: Serenity Body Position Sensor, Serenity RIP Sensors (2018), 1 descendant of its own
- K251366: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (2025), 0 descendants of its own

## Indications for use
The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

Source page: https://510kreport.com/device/K080546
Methodology: https://510kreport.com/methodology