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Cardiophonics Memory Transmitter

by Rlt Medical Assoc., Inc.

510(k) K915224

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 NumberK915224 Date7 Feb 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  • Withdrawn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, 27 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 Cardiophonics Memory Transmitter is a transmitter and receiver, electrocardiograph, telephone, classified as a device with a product code of DXH. It is used in the medical specialty of Cardiovascular. The device is substantially equivalent to other devices and has a regulation number of 870.2920.

The device was cleared on February 7, 1992, with a 510(k) number of K915224. It is supplied by Rlt Medical Assoc., Inc. and has a medical specialty description of Cardiovascular. The device has a device class of 2 and is registered with the FDA.

Other devices from Rlt Medical Assoc., Inc.

Questions

AI-generated answers, 27 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 Cardiophonics Memory Transmitter used for?

    The Cardiophonics Memory Transmitter is used in the medical specialty of Cardiovascular, specifically as a transmitter and receiver, electrocardiograph, and telephone.

  • Is the Cardiophonics Memory Transmitter supplied sterile?

    The device data does not specify whether the Cardiophonics Memory Transmitter is supplied sterile, it is recommended to consult the manufacturer or device labeling for this information.

  • What is the regulatory classification of the Cardiophonics Memory Transmitter?

    The Cardiophonics Memory Transmitter has a device class of 2 and is registered with the FDA under regulation number 870.2920.

  • What is the product code of the Cardiophonics Memory Transmitter?

    The product code of the Cardiophonics Memory Transmitter is DXH.