# K962157: Model 1310 Neurolink Neuromonitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Physiometrix, Inc.
- Decided: Nov 25, 1996 after 174 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 K930080 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K970942: Model 1320, Neurolink II Neuromonitoring System (1997), 0 descendants of its own

## Indications for use
The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment.

Source page: https://510kreport.com/device/K962157
Methodology: https://510kreport.com/methodology