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Cardio Perfect, Cardio Perfect MD

by Cardio Control BV

510(k) K913374

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 NumberK913374 Date23 Jan 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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Cardio Perfect, Cardio Perfect MD is an electrocardiograph device used for cardiovascular applications. It is designed to record and analyze electrical activity of the heart to assist in cardiac assessment.

The device is supplied by Cardio Control BV and is classified as a Class II medical device with FDA 510(k) clearance. It is available in multiple models including K913374 and K922898, with the latter being cleared on November 1, 1993. The device is regulated under product code DPS and is intended for cardiovascular medical specialty use.

Other devices from Cardio Control BV

Questions

AI-generated answers, 26 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 Cardio Perfect device used for?

    The Cardio Perfect is an electrocardiograph device designed to record and analyze the electrical activity of the heart to assist in cardiac assessment. It is intended for cardiovascular medical specialty use.

  • What models of the Cardio Perfect are available?

    The Cardio Perfect is available in multiple models including K913374 and K922898, with the latter being cleared on November 1, 1993. Each model may have specific features or applications.

  • How is the Cardio Perfect device classified?

    The Cardio Perfect is classified as a Class II medical device with FDA 510(k) clearance. It is regulated under product code DPS and is intended for cardiovascular medical specialty use.

  • What is the regulatory status of the Cardio Perfect?

    The Cardio Perfect has FDA 510(k) clearance with a decision date of January 23, 1992. It was determined to be substantially equivalent to predicate devices and reviewed by the Cardiovascular advisory committee.