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1710 Monitoring ECG Electrode

by Conmed Andover Medical, Inc.

510(k) K944726

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 NumberK944726 Date22 Nov 1994ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
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.

The 1710 Monitoring ECG Electrode is a disposable electrode intended for electrocardiogram (ECG) monitoring. It provides a conductive interface between the patient’s skin and ECG recording equipment to capture cardiac electrical activity.

The device was cleared by the U.S. Food and Drug Administration through a traditional 510(k) submission (K944726) and is classified under product code DRX. It is marketed by Conmed Andover Medical, Inc. and is supplied as a single‑use item for clinical monitoring settings.

Other devices from Conmed Andover Medical, Inc.

See all devices from Conmed Andover Medical, Inc. →

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 intended use of the 1710 Monitoring ECG Electrode?

    It is designed as a disposable electrode to create a conductive link between a patient’s skin and ECG recording equipment, enabling reliable capture of cardiac electrical activity during clinical monitoring.

  • How is the 1710 Monitoring ECG Electrode supplied and intended for reuse?

    The electrode is supplied as a single‑use item, meaning each unit is intended for one patient encounter only and should be discarded after use to maintain sterility and performance.

  • What regulatory pathway was used for the 1710 Monitoring ECG Electrode?

    The device received clearance through a traditional 510(k) submission (K944726) and is classified under product code DRX, indicating it was found substantially equivalent to a legally marketed predicate.

  • In what clinical settings is the 1710 Monitoring ECG Electrode typically used?

    It is marketed for use in clinical monitoring environments such as hospitals, ambulatory care, and other settings where continuous or intermittent ECG monitoring is required, providing a reliable interface for cardiac waveform acquisition.