# K900482: Software & Hardware Addition to Sentinel-4 Eeg

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Jun 20, 1990 after 139 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
465 later devices descend from it; 1 cites it directly.
1 of 466 devices in its family (counting itself) has 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
- K971819: Epoch 2000 Neurological Workstation (1997), 464 descendants of its own
- K022785: Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation (2002), 463 descendants of its own
- K032741: Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation (2003), 462 descendants of its own
- K050798: Eclipse Neurological Workstation (2005), 460 descendants of its own
- K061113: Orthomon (2006), 450 descendants of its own

Source page: https://510kreport.com/device/K900482
Methodology: https://510kreport.com/methodology