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Telephone Electrocardiograph Transmitter

by Rlt Medical Assoc., Inc.

510(k) K934975

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 NumberK934975 Date6 Apr 1995ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Telephone Electrocardiograph Transmitter is a Class II medical device classified under Transmitters and Receivers, Electrocardiograph, Telephone. It is designed to condition an electrocardiogram (ECG) signal for transmission over telephone lines, enabling remote monitoring and transmission of cardiac data to a receiving location. This facilitates real-time or delayed review of ECG recordings by healthcare providers, enhancing diagnostic capabilities in cardiovascular care.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as hospitals, emergency rooms, or cardiology clinics. It operates under standard electrical safety standards and does not require MRI compatibility considerations. The device was cleared by the FDA through a 510(k) submission (K934975) under the Substantially Equivalent determination, adhering to regulatory classification 870.2920. No specific sterility or single-use requirements are noted in the regulatory data.

Other devices from Rlt Medical Assoc., Inc.

Questions

AI-generated answers, 1 Oct 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 Telephone Electrocardiograph Transmitter used for?

    The Telephone Electrocardiograph Transmitter is designed to condition and transmit electrocardiogram (ECG) signals over telephone lines. This enables healthcare providers to remotely review ECG recordings in real-time or asynchronously, improving diagnostic capabilities for cardiovascular care in settings like hospitals, emergency rooms, or cardiology clinics.

  • Is the Telephone Electrocardiograph Transmitter reusable or single-use?

    The Telephone Electrocardiograph Transmitter is supplied as a reusable medical instrument. It is intended for repeated use in clinical environments, provided it is properly maintained and cleaned according to manufacturer guidelines.

  • Does the Telephone Electrocardiograph Transmitter require any special handling for sterility?

    The regulatory data for this device does not specify any sterility requirements. Since it is reusable, it should be cleaned and maintained according to standard medical device reprocessing protocols to ensure safety and functionality.

  • What regulatory pathway was followed for this device?

    The Telephone Electrocardiograph Transmitter was cleared by the FDA through a 510(k) submission (K934975) under the Substantially Equivalent determination. This device falls under the classification for Transmitters and Receivers, Electrocardiograph, Telephone, and adheres to regulatory classification 870.2920.

  • Can this device be used in environments with MRI machines?

    No, the Telephone Electrocardiograph Transmitter is not designed for use in MRI environments. It operates under standard electrical safety standards and does not include features or certifications for MRI compatibility.