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Electrocardiograph EK-7 (3-CHANNELS)

by Burdick Corp. 510(k)

Active United States

510(k) K760271

Overview

An electrocardiograph is a device that records the electrical activity of the heart. The EK-7 (3-Channels) model is a 3-channel electrocardiograph designed for acquiring and displaying cardiac electrical signals.

This device is supplied as a reusable instrument intended for use in clinical settings. It has received FDA 510(k) clearance (K760271) and is classified as a Class II medical device under product code DPS with special controls. The device was cleared on November 15, 1976, following a traditional review process.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760271 Date15 Nov 1976ClearedStatusActive

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
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  • 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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EK-7 electrocardiograph used for?

    The EK-7 is a 3-channel electrocardiograph designed for acquiring and displaying cardiac electrical signals, helping healthcare professionals monitor heart activity in clinical settings.

  • Is the EK-7 a single-use or reusable device?

    The EK-7 is supplied as a reusable instrument intended for use in clinical settings, allowing for multiple patient examinations when properly maintained and cleaned.

  • What regulatory approvals does the EK-7 have?

    The EK-7 has received FDA 510(k) clearance (K760271) and is classified as a Class II medical device under product code DPS with special controls, cleared on November 15, 1976.

  • How many channels does the EK-7 electrocardiograph have?

    The EK-7 model is specifically designed as a 3-channel electrocardiograph, allowing for simultaneous recording of electrical signals from three different heart leads.