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Nicom Electrodes

by Cheetah Medical, Inc.

510(k) K071631

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071631 Date18 Jan 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Nicom Electrodes are diagnostic components used in conjunction with hemodynamic monitoring systems. These electrodes facilitate the non-invasive collection of physiological data for cardiac output monitoring.

This device is supplied by Cheetah Medical, Inc. and has received FDA 510K authorization. It is classified under the cardiovascular medical specialty for use in diagnostic settings.

Other devices from Cheetah Medical, Inc.

Questions

AI-generated answers, 26 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 purpose of Nicom Electrodes?

    Nicom Electrodes are diagnostic components used in conjunction with hemodynamic monitoring systems. They are specifically designed to facilitate the non-invasive collection of physiological data required for cardiac output monitoring.

  • In what medical specialty are these electrodes used?

    These electrodes are classified under the cardiovascular medical specialty. They are intended for use in diagnostic settings where hemodynamic monitoring is required.

  • What is the regulatory status of this device?

    Nicom Electrodes have received FDA 510K authorization. This indicates that the device has been reviewed and cleared for use in the United States under the specified regulatory pathway.