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Card GUARD-3000 ECG Telephone Adapter

by Medtech Industries, Inc. 510(k)

Active United States

510(k) K910450

Overview

The Card Guard-3000 ECG Telephone Adapter is a transmitter and receiver, electrocardiograph, telephone device used to condition an electrocardiograph signal so that it can be transmitted via a telephone. It is classified under regulation number 870.2920 and product code DXH, with a medical specialty in cardiovascular.

The device received FDA 510(k) clearance K910450 on May 7, 1991, following a traditional review process, and was found substantially equivalent. It was manufactured by Medtech Industries, Inc., and is associated with multiple facility establishment identifiers and registration numbers as listed in the specifications.

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 NumberK910450 Date7 May 1991ClearedStatusActive

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

Other devices from Medtech Industries, Inc.

Questions

  • What is the Card Guard-3000 ECG Telephone Adapter used for?

    The Card Guard-3000 ECG Telephone Adapter is used to condition an electrocardiograph signal so that it can be transmitted via a telephone. It functions as both a transmitter and receiver for ECG data over telephone lines, enabling remote transmission of cardiac monitoring information.

  • How is the Card Guard-3000 ECG Telephone Adapter supplied and is it reusable?

    The device data does not specify whether the Card Guard-3000 ECG Telephone Adapter is supplied sterile, non-sterile, single-use, or reusable. As a telephone adapter for ECG signal conditioning, it is likely intended for repeated use in clinical or home settings, but reuse protocols would depend on manufacturer instructions not included in the provided data.

  • What regulatory pathway was used for the Card Guard-3000 ECG Telephone Adapter?

    The Card Guard-3000 ECG Telephone Adapter received FDA 510(k) clearance through a traditional review process. It was found substantially equivalent to a predicate device, with clearance granted on May 7, 1991, under K910450. This indicates it followed the standard premarket notification route for moderate-risk medical devices.