# K971331: Satellite

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Jun 25, 1997 after 76 days
- Product code: GWQ (Full-Montage Standard 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 K946094 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946094: Cadwell Easy Ambulatory Eeg, Cadwell Laboratories, Inc. (1995) Summary page 2.
- K954954: Ceegraph Traveler Ambulatory Eeg Recorder, Bio-Logic Systems Corp. (1996) Summary page 2.

## Indications for use
The Sateliite is intended to acquire EEG data from patients that are stationary or ambulatory, regardless of whether they are inside or outside a medical-care facility.

Source page: https://510kreport.com/device/K971331
Methodology: https://510kreport.com/methodology