# K011204: Neurofax, Models Eeg-1100A, Eeg-9100A

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: May 8, 2001 after 19 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
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022121: PSG Input Box, Model JE-912AK (2002), 9 descendants of its own
- K062943: Polysmith Sleep System, Model NTI5498 (2007), 7 descendants of its own
- K050833: Electrode Junction Box, Model JE-921A (2005), 7 descendants of its own
- K120888: PSG-1100 Sleep Diagnostic System (2012), 6 descendants of its own
- K142774: Polysmith Sleep System (2015), 4 descendants of its own

Source page: https://510kreport.com/device/K011204
Methodology: https://510kreport.com/methodology