# K961609: Model 1220, or E-Net (54-62 CM)

- Pathway: 510(k) (Traditional)
- Applicant: Physiometrix, Inc.
- Decided: May 10, 1996 after 15 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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 K930080 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930080: E*Net Neuromonitoring System, Physiometrix, Inc. (1993) Summary page 1.

## Indications for use
Headpiece for EEG Monitoring in Operating Room

Source page: https://510kreport.com/device/K961609
Methodology: https://510kreport.com/methodology