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Arrhythmia Printer Option

by American Edwards Laboratories 510(k)

Active United States

510(k) K811792

Overview

This device is a Detector and Alarm, Arrhythmia, designed to identify and alert clinicians to cardiac arrhythmias. It functions as an accessory to monitor and record abnormal heart rhythms, aiding in the diagnosis and management of arrhythmic events in clinical settings.

The Arrhythmia Printer Option is intended for use in healthcare environments, where it connects to monitoring systems to print arrhythmia events for review. Supplied as a reusable component, it requires proper calibration and maintenance. The device holds an FDA 510(k) clearance (K811792) under the DSI product code, with a classification as Class II. No information regarding MRI safety, sterility, or specific storage conditions is provided in the available data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811792 Date10 Jul 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Arrythmia Printer Option
510(k) Number
FDA Product Code
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Arrhythmia Printer Option used for?

    The Arrhythmia Printer Option is designed as a detector and alarm system to identify and alert clinicians to cardiac arrhythmias. It connects to monitoring systems to print arrhythmia events, helping healthcare providers diagnose and manage abnormal heart rhythms in clinical environments.

  • Is the Arrhythmia Printer Option reusable or single-use?

    The device is supplied as a reusable component. It requires proper calibration and maintenance to ensure accurate detection and reliable performance over multiple uses.

  • What regulatory approval does the Arrhythmia Printer Option hold?

    The Arrhythmia Printer Option holds FDA 510(k) clearance (K811792) under the DSI product code, classified as a Class II device. This clearance indicates it has been determined substantially equivalent to a legally marketed device.

  • Are there specific storage conditions or MRI safety information for this device?

    The provided data does not include details regarding MRI safety or specific storage conditions for the Arrhythmia Printer Option. Users should follow general best practices for medical device storage unless manufacturer guidelines specify otherwise.

  • How does the Arrhythmia Printer Option integrate with existing monitoring systems?

    The device functions as an accessory to monitoring systems, specifically designed to print arrhythmia events for review. It connects directly to these systems to provide printed records of detected arrhythmias, facilitating clinical assessment and patient management.