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Cardioset (Hardware), Model HO4; Cardioset Scl (Software), Model V3.01

by Next Millennium Software Solutions, Inc.

510(k) K001091

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 NumberK001091 Date10 Aug 2000ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 device is a transmitter and receiver, electrocardiograph, telephone, as classified under regulation number 870.2920. It consists of hardware (Cardioset, Model HO4) and software (Cardioset SCL, Model V3.01) components designed for cardiovascular applications.

It was cleared via the FDA 510(k) pathway under K001091 by Next Millennium Software Solutions, Inc., with a traditional clearance decision dated August 10, 2000. The device is intended for use in cardiovascular settings and is supplied as a system comprising both hardware and software elements.

Questions

AI-generated answers, 24 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 Cardioset system intended for?

    The Cardioset system is intended for use in cardiovascular settings as a transmitter and receiver, electrocardiograph, and telephone, designed for cardiovascular applications involving ECG signal transmission and reception.

  • What components make up the Cardioset system and what are their model numbers?

    The Cardioset system consists of two components: hardware named Cardioset with Model HO4 and software named Cardioset SCL with Model V3.01, which together form a complete system for cardiovascular ECG transmission and reception.

  • How was the Cardioset system cleared for market release?

    The Cardioset system was cleared via the FDA 510(k) pathway under submission number K001091 by Next Millennium Software Solutions, Inc., receiving a traditional clearance decision on August 10, 2000, based on a determination of substantial equivalence.