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Carefusion Nicolet EDX

by Carefusion 209, Inc. 2 variants

510(k) K120979

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 · Special NumberK120979 Date25 Apr 2012ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The Carefusion Nicolet EDX is an electrical stimulator for evoked response. It is designed for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems, including nerve conduction and electromyography.

This device is classified as a Class II medical device under regulation number 882.1870. It has received FDA 510(k) clearance under the identifier K120979.

Other devices from Carefusion 209, Inc.

Questions

AI-generated answers, 21 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 primary function of the Carefusion Nicolet EDX?

    The device is an electrical stimulator designed for evoked response testing. It facilitates the acquisition, display, analysis, storage, and reporting of electrophysiological information derived from the human nervous and muscular systems, including nerve conduction and electromyography.

  • What is the regulatory classification of this device?

    The Carefusion Nicolet EDX is classified as a Class II medical device under regulation number 882.1870. It has received FDA 510(k) clearance under the identifier K120979.

  • Which medical specialty is this device associated with?

    The device is categorized under the Neurology advisory committee, reflecting its intended use in monitoring and analyzing the electrical activity of the nervous and muscular systems.