# K060997: Snap II Eeg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Everest Biomedical Instruments Co.
- Decided: Jun 15, 2006 after 66 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- 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: 3 generations back to K874685 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020218: Snap Eeg Monitor, Nicolet Biomedical, Inc. (2002) Summary page 2.

## Indications for use
The SNAP Il is intended to monitor the state of the brain by data acquisition of EEG signals. A derived measure provided by the SNAP I, the SNAP Index, indicates the patient’s brain activity level. The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.

Source page: https://510kreport.com/device/K060997
Methodology: https://510kreport.com/methodology