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NeuroNet

by Computational Diagnostics, Inc.

510(k) K952294

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952294 Date26 Jan 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

NeuroNet is an electrical stimulator device used for evoked response monitoring. It is designed to collect and analyze neurophysiological data during surgical procedures.

The NeuroNet system is supplied for use in intraoperative neurophysiological monitoring. It is a Class II device cleared by the FDA under 510(k) K952294. The device is manufactured by Computational Diagnostics, Inc. and is intended for use in neurology procedures.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NeuroNet device used for?

    NeuroNet is an electrical stimulator device designed to collect and analyze neurophysiological data during surgical procedures, specifically for intraoperative neurophysiological monitoring in neurology procedures.

  • How is the NeuroNet system supplied?

    The NeuroNet system is supplied for use in intraoperative neurophysiological monitoring. It is a Class II device manufactured by Computational Diagnostics, Inc.

  • What is the regulatory status of the NeuroNet device?

    The NeuroNet device is a Class II device cleared by the FDA under 510(k) K952294 with a decision date of 1996-01-26, determined to be substantially equivalent.

  • What is the product code for NeuroNet?

    The NeuroNet device has a product code of GWF, which is an administrative field indicating how the submission was filed with the FDA.