Skip to content

Cardionavigator Information Management System

by Reynolds Medical, Ltd.

510(k) K011345

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 NumberK011345 Date20 Jul 2001ClearedStatusActive

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  • Withdrawn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
FDA applicant
Reynolds Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Cardionavigator Information Management System is a transmitter and receiver, electrocardiograph, telephone, classified as a class 2 device. It is used in the cardiovascular medical specialty. The system is substantially equivalent to existing devices and is used for information management in the field of cardiology.

The Cardionavigator Information Management System is supplied with a product code of DXH and a regulation number of 870.2920. It was cleared by the FDA on July 20, 2001, with a 510(k) number of K011345. The device is not third-party reviewed and has a traditional clearance type. It is intended for use in a cardiovascular setting and is classified as a transmitter and receiver, electrocardiograph, telephone.

Other devices from Reynolds Medical, Ltd.

See all devices from Reynolds Medical, Ltd. →

Questions

AI-generated answers, 21 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 Cardionavigator System used for?

    The Cardionavigator System is used for information management in the field of cardiology, specifically in a cardiovascular setting.

  • Is the Cardionavigator System a single-use or reusable device?

    The device data does not specify whether the Cardionavigator System is single-use or reusable, but it is classified as a transmitter and receiver, electrocardiograph, telephone.

  • What is the regulatory classification of the Cardionavigator System?

    The Cardionavigator System is classified as a class 2 device with a product code of DXH and a regulation number of 870.2920.

  • When was the Cardionavigator System cleared by the FDA?

    The Cardionavigator System was cleared by the FDA on July 20, 2001, with a 510(k) number of K011345.