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Microprocessor Controlled Electrocardio

by Honeywell, Inc.

510(k) K810263

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 NumberK810263 Date19 Feb 1981ClearedStatusActive

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  • Withdrawn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, 25 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 Microprocessor Controlled Electrocardio is a cardiovascular device designed to perform electrocardiographic monitoring and analysis. It utilizes microprocessor technology to process cardiac electrical signals for clinical evaluation.

This device is identified by FDA 510(k) number K810263 and is classified under product code DPS. It received FDA 510(k) clearance on February 19, 1981, following a traditional review process.

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Questions

AI-generated answers, 25 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 primary function of the Microprocessor Controlled Electrocardio?

    This device is designed to perform electrocardiographic monitoring and analysis. It utilizes integrated microprocessor technology to process cardiac electrical signals, which allows clinicians to perform a detailed clinical evaluation of a patient's heart activity.

  • What is the regulatory status of this device?

    The Microprocessor Controlled Electrocardio received FDA 510(k) clearance on February 19, 1981, under the submission number K810263. It was determined to be substantially equivalent to existing devices through a traditional review process.

  • How is this device classified for regulatory purposes?

    The device is classified under the product code DPS, which falls under the oversight of the Cardiovascular advisory committee. This classification reflects how the device was filed and reviewed by the FDA during its initial authorization process.