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Taylor Long Term Monitoring Electrode

by Taylor Industries, Inc.

510(k) K941977

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 NumberK941977 Date21 Sep 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  • Withdrawn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, 27 Sep 2026

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

A long term monitoring electrode is a device intended for use in monitoring physiological signals over extended periods. It is designed to interface with monitoring systems to capture and transmit electrical activity from the body.

This electrode is supplied as a single-use device and is intended for use in clinical settings such as hospitals or outpatient facilities. It is not sterile and does not require special storage conditions beyond standard handling. The device is not evaluated for MRI safety and has no stated size variations in the provided data. Authorization is based on FDA 510(k) clearance K941977, granted on September 21, 1994, under product code DRX.

Other devices from Taylor Industries, Inc.

Questions

AI-generated answers, 27 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 Taylor Long Term Monitoring Electrode used for?

    It is intended for monitoring physiological signals over extended periods by interfacing with monitoring systems to capture and transmit electrical activity from the body in clinical settings such as hospitals or outpatient facilities.

  • Is the Taylor Long Term Monitoring Electrode sterile or single-use?

    The device is supplied as a single-use electrode and is not sterile; it is designed for one-time use and does not require sterilization prior to use.

  • Does the Taylor Long Term Monitoring Electrode require special storage conditions?

    No special storage conditions are needed beyond standard handling; the device does not require refrigeration, humidity control, or other specific environmental controls for storage.

  • What regulatory pathway was used for the Taylor Long Term Monitoring Electrode?

    The device received FDA 510(k) clearance under K941977, granted on September 21, 1994, based on a determination of substantial equivalence to a predicate device.