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G3000 OR AG2000 - Disposable Resting Electrode

by Cmc Sense-It, Inc.

510(k) K955815

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 NumberK955815 Date23 Jul 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  • Withdrawn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
DRX
Models / Variants
Disposable Resting Electrode
Device Class
Class II
Regulation
21 CFR Part 870.2360
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.

The G3000 or AG2000 is a disposable resting electrode designed for clinical use. It functions as a medical electrode to facilitate the monitoring of electrical signals from the body.

This device is supplied as a single-use component and is subject to FDA 510k authorization. It is categorized under product code DRX for use in cardiovascular applications.

Other devices from Cmc Sense-It, 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 clinical application for the G3000 or AG2000 electrode?

    The G3000 or AG2000 is designed to facilitate the monitoring of electrical signals from the body. It is specifically categorized for use in cardiovascular applications.

  • Is the G3000 or AG2000 intended for multiple uses?

    No, this device is supplied as a single-use component. It must be disposed of after the initial clinical application to ensure proper hygiene and signal integrity.

  • What is the regulatory status of this electrode?

    The G3000 or AG2000 is subject to FDA 510k authorization under K-number K955815. It was determined to be substantially equivalent for its intended use in cardiovascular monitoring.