# K970942: Model 1320, Neurolink II Neuromonitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Physiometrix, Inc.
- Decided: Jun 2, 1997 after 80 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: 2 generations back to K930080 (1993). 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)
- K962157: Model 1310 Neurolink Neuromonitoring System, Physiometrix, Inc. (1996). Our OCR of the scanned summary read K862157, FDA’s number for Omc Orthomet Cannulated Screw (Orthomet, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NeuroLink NeuroMonitoring System, Model 1310”.

## Indications for use
System for recording electroencephalogram of brain electrical activity to Host Digital EEG Machine.

Source page: https://510kreport.com/device/K970942
Methodology: https://510kreport.com/methodology