# K992742: Neurofax, Model Eeg-1100A

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Oct 14, 1999 after 59 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- 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: 1 generation back to K944678 (1995). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944678: Nihon Kohden Electroencephalograph, Nihon Kohden America, Inc. (1995) Summary page 1.

## Most influential descendants
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A (2008), 11 descendants of its own
- K120888: PSG-1100 Sleep Diagnostic System (2012), 6 descendants of its own
- K073491: Eeg-1100A Switch Box (2008), 5 descendants of its own
- K142774: Polysmith Sleep System (2015), 4 descendants of its own
- K082629: S12X with Esax Option (2009), 4 descendants of its own

## Indications for use
The EEG-1100A 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 Disorders, 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/K992742
Methodology: https://510kreport.com/methodology