# K073491: Eeg-1100A Switch Box

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jan 11, 2008 after 30 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: 2 generations back to K944678 (1995). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 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
- K082629: S12X with Esax Option (2009), 4 descendants of its own
- K151354: Cervello STIM (2016), 2 descendants of its own
- K180761: SD LTM STIM Cortical Stimulator (2018), 1 descendant of its own
- K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (2025), 0 descendants of its own
- K173684: g.Estim PRO (2018), 0 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 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 or a medical facility under direct supervision of a medical professional.

Source page: https://510kreport.com/device/K073491
Methodology: https://510kreport.com/methodology