Equinox Digital EEG System

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

510(k) Number

K962447 ↗

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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See all devices from Physiometrix, Inc. →

• What is the Equinox Digital EEG System used for?

  The Equinox Digital EEG System is a Full-Montage Standard Electroencephalograph designed for neurology applications to record electroencephalographic activity, as stated in its device description.

• How is the Equinox Digital EEG System supplied and what components does it include?

  The system is supplied as a reusable system and includes Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic cable, DSP Interface Card, and computer hardware, according to the device data.

• Is the Equinox Digital EEG System reusable or single-use?

  The Equinox Digital EEG System is supplied as a reusable system, meaning its components are intended for multiple uses after appropriate cleaning and reprocessing, as indicated in the description.

• What regulatory pathway was used for the Equinox Digital EEG System?

  The Equinox Digital EEG System received FDA 510(k) clearance under K962447, which is a traditional 510(k) submission pathway for demonstrating substantial equivalence to a legally marketed device.

• What is the device classification of the Equinox Digital EEG System?

  The Equinox Digital EEG System is classified as a Class II device, as specified in the openfda field showing device_class=2 and confirmed by its FDA 510(k) clearance.