Model 1310 Neurolink Neuromonitoring System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K962157 ↗

FDA Product Code

GWQ

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What is the Model 1310 Neurolink Neuromonitoring System used for?

  The Model 1310 Neurolink Neuromonitoring System is intended for use in clinical neurology settings for electroencephalographic monitoring as specified in its FDA 510(k) clearance documentation, providing full-montage standard EEG functionality for neurology applications.

• How was the Model 1310 Neurolink Neuromonitoring System cleared for market?

  The Model 1310 Neurolink Neuromonitoring System was cleared under the FDA 510(k) process as a substantially equivalent device, with clearance granted on November 25, 1996, under K962157, based on its equivalence to a legally marketed predicate device.

• What regulatory identifiers are associated with the Model 1310 Neurolink Neuromonitoring System?

  The Model 1310 Neurolink Neuromonitoring System is associated with product code GWQ, regulation number 882.1400, and FDA 510(k) number K962157, and is classified as a Class II device under the Full-Montage Standard Electroencephalograph device name.