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Phoenix Digital EEG

by Axon Systems, Inc. 510(k)

Active United States

510(k) K002316

Overview

The Phoenix Digital EEG is a full-montage standard electroencephalograph device used for neurological assessments. It captures and records electrical activity in the brain to assist in diagnosing and monitoring neurological conditions.

This device is supplied by Axon Systems, Inc. and is a Class II medical device regulated under product code GWQ. It received FDA 510(k) clearance on October 26, 2000, with K-number K002316. The device is intended for use in clinical settings by healthcare professionals for neurological evaluations.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002316 Date26 Oct 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
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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Questions

  • What is the Phoenix Digital EEG used for?

    The Phoenix Digital EEG is a full-montage standard electroencephalograph device used for neurological assessments. It captures and records electrical activity in the brain to assist healthcare professionals in diagnosing and monitoring neurological conditions in clinical settings.

  • How is the Phoenix Digital EEG supplied and what is its regulatory classification?

    The Phoenix Digital EEG is supplied by Axon Systems, Inc. and is classified as a Class II medical device under product code GWQ. It received FDA 510(k) clearance on October 26, 2000, with K-number K002316, making it substantially equivalent to other devices in its class.

  • Is the Phoenix Digital EEG reusable or single-use?

    The device information does not specify whether the Phoenix Digital EEG is reusable or single-use. As a Class II medical device, its usage would depend on the manufacturer's instructions and healthcare facility protocols regarding device reprocessing or disposal.

  • What sizes or models of the Phoenix Digital EEG are available?

    The device data does not specify different sizes or models of the Phoenix Digital EEG. The information provided indicates a single device type, the PHOENIX DIGITAL EEG, which is a full-montage standard electroencephalograph for neurological assessments.