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ECG Modulator

by Maguire Ent., Inc.

510(k) K922412

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 NumberK922412 Date6 Jul 1992ClearedStatusActive

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  • Withdrawn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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 ECG Modulator is a device classified as a Transmitter and Receiver, Electrocardiograph, Telephone under FDA regulations. It is designed for use in cardiovascular applications as indicated by its advisory committee classification.

The device received traditional 510(k) clearance (K922412) on July 6, 1992, and is manufactured by Maguire Ent., Inc. It is supplied as a non-sterile, reusable device intended for use in clinical settings, with no MRI safety information or single-use designation provided in the data.

Questions

AI-generated answers, 23 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 ECG Modulator used for?

    The ECG Modulator is designed for use in cardiovascular applications as indicated by its advisory committee classification under FDA regulations, functioning as a Transmitter and Receiver, Electrocardiograph, Telephone device.

  • Is the ECG Modulator sterile or single-use?

    The ECG Modulator is supplied as a non-sterile, reusable device, with no single-use designation or sterility information provided in the device data, indicating it is intended for repeated use in clinical settings after appropriate cleaning.

  • How was the ECG Modulator cleared for market?

    The ECG Modulator received traditional 510(k) clearance (K922412) from the FDA on July 6, 1992, based on a determination of substantial equivalence to a legally marketed predicate device.