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EKG SPEAKS

by Medtronic Vascular

510(k) K032926

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 · Special NumberK032926 Date15 Oct 2003ClearedStatusActive

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  • Withdrawn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
KRE
Device class
Class II
Regulation
21 CFR Part 870.3640
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.

The EKG SPEAKS is an analyzer for pacemaker generator function, indirect. It is classified under product code KRE and is designed for cardiovascular applications.

The device is manufactured by Medtronic Vascular in Minneapolis, US. It received FDA 510(k) clearance on October 15, 2003, with a decision code of SESE (Substantially Equivalent). The device is Class II with special controls and is not indicated for promoting embolization.

Other devices from Medtronic Vascular, Inc.

See all devices from Medtronic Vascular, 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 EKG SPEAKS analyzer used for?

    The EKG SPEAKS analyzer is designed for evaluating pacemaker generator function indirectly in cardiovascular applications. It helps clinicians assess the performance of pacemaker generators through indirect analysis methods.

  • How is the EKG SPEAKS device supplied and what are its sterility requirements?

    The device is supplied as a medical analyzer for professional use. While the specific sterility requirements aren't detailed in the provided information, it's designed for clinical environments where proper handling and maintenance protocols would be followed.

  • Is the EKG SPEAKS device reusable or single-use?

    The device information doesn't specify whether it's designed for single-use or multiple uses. As an analyzer for pacemaker generator function, it's likely intended for repeated clinical use with appropriate maintenance and calibration procedures.

  • What regulatory status does the EKG SPEAKS analyzer have?

    The EKG SPEAKS analyzer received FDA 510(k) clearance on October 15, 2003, with a decision code of SESE (Substantially Equivalent). It is classified as Class II with special controls for cardiovascular applications.