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Dash 3000/4000 Patient Monitor

by General Electric Medical Systems Information Techn 2 variants

510(k) K001359

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K001359; other models may be affected

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 NumberK001359 Date18 Jul 2000ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0520-2019 FDA Class II initiated 31 Aug 2018 on shared 510(k) K001359

    The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Dash 3000/4000 Patient Monitor is a device intended for monitoring physiologic parameter data on adult, pediatric, and neonatal patients under the direct supervision of a licensed healthcare practitioner. It is classified as a Detector and Alarm, Arrhythmia device under FDA device class 2.

The device received FDA 510(k) clearance (K001359) on July 18, 2000, as substantially equivalent to a predicate device. It is manufactured by General Electric Medical Systems Information Techn and is supplied as a reusable patient monitoring system for use in clinical settings under professional supervision.

Other devices from General Electric Medical Systems Information Techn

See all devices from General Electric Medical Systems Information Techn →

Questions

AI-generated answers, 1 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 Dash 3000/4000 Patient Monitor used for?

    The Dash 3000/4000 Patient Monitor is intended for monitoring physiologic parameter data on adult, pediatric, and neonatal patients under the direct supervision of a licensed healthcare practitioner. It functions as a detector and alarm device for arrhythmia detection, providing continuous monitoring of vital signs in clinical settings.

  • Is the Dash 3000/4000 Patient Monitor reusable or single-use?

    The Dash 3000/4000 Patient Monitor is supplied as a reusable patient monitoring system, meaning it is designed for multiple uses after proper cleaning and disinfection between patients, in accordance with the manufacturer’s instructions for use and infection control protocols.

  • Who manufactures the Dash 3000/4000 Patient Monitor and where is it made?

    The Dash 3000/4000 Patient Monitor is manufactured by General Electric Medical Systems Information Techn, with the manufacturer’s address listed as 8200 W. Tower Ave., Milwaukee, WI 53223, United States, as indicated in the device’s registration and clearance documentation.