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Cardiocollect Portable Electrocardiograph

by Reynolds Medical, Ltd.

510(k) K013367

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 NumberK013367 Date13 Dec 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  • Withdrawn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
DPS
FDA applicant
Reynolds Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH is a battery-powered digital electrocardiograph designed for acquiring 12-lead ECGs from patients. It is used by technicians to capture cardiac electrical activity and can print results directly via connected printer or store them digitally in a patient record within a computer system. The device supports data handling for up to 40 patients.

This single-use device is intended for clinical settings where portable ECG acquisition is required. It operates on a rechargeable battery and connects directly to a printer for output. The device is cleared under FDA 510(k) with product code DPS and is classified under the Cardiovascular advisory committee. It is stored in a standard clinical environment and is not MRI compatible.

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Questions

AI-generated answers, 6 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 CARDIOCOLLECT Portable Electrocardiograph used for?

    The CARDIOCOLLECT Portable Electrocardiograph is used by technicians to capture cardiac electrical activity from patients. It is designed for acquiring 12-lead ECGs in clinical settings where portable ECG acquisition is required, allowing for both direct printing and digital storage of results.

  • How is the device supplied and powered?

    The device is supplied as a battery-powered digital electrocardiograph. It operates on a rechargeable battery and connects directly to a printer for output, making it suitable for portable use in various clinical settings.

  • Is the device single-use or reusable?

    The device is described as a single-use device. This classification indicates it is intended for one-time use per patient or per session, aligning with its design for clinical settings where portable ECG acquisition is required.

  • What are the data handling capabilities of the device?

    The device supports data handling for up to 40 patients. It can store results digitally in a patient record within a computer system or print them directly via a connected printer, facilitating efficient patient data management.

  • Where should the device be stored and what are its compatibility limitations?

    The device is stored in a standard clinical environment. It is not MRI compatible, meaning it should not be used in or near MRI environments due to potential safety or functionality issues.