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ECG Monitoring System

by Quinton, Inc. 510(k)

Active United States

510(k) K780404

Overview

The ECG Monitoring System is a cardiac monitoring device that includes a cardiotachometer and rate alarm. It is designed to monitor cardiac activity and provide real-time data on heart rate and rhythm.

The device is manufactured by Quinton, Inc. and has FDA 510(k) clearance with the K780404 number. It is classified as a Class II device under product code DRT with special controls. The system is intended for use in cardiovascular settings and is supplied in various models as indicated by the multiple registration numbers provided.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780404 Date28 Mar 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the ECG Monitoring System used for?

    The ECG Monitoring System is designed to monitor cardiac activity and provide real-time data on heart rate and rhythm. It includes a cardiotachometer and rate alarm functionality, making it suitable for cardiovascular settings.

  • How is the ECG Monitoring System supplied?

    The system is manufactured by Quinton, Inc. and is available in various models as indicated by the multiple registration numbers provided. Each model may have specific configurations or features tailored to different clinical needs.

  • What is the regulatory status of the ECG Monitoring System?

    The ECG Monitoring System has FDA 510(k) clearance with the K780404 number. It is classified as a Class II device under product code DRT with special controls, indicating it meets specific regulatory requirements for safety and effectiveness.

  • Is the ECG Monitoring System reusable or single-use?

    The device data does not specify whether the ECG Monitoring System is reusable or single-use. This information would typically be found in the product's instructions for use or labeling provided by the manufacturer.