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Eagle 3000/3100 Patient Monitor

by Marquette Electronics, Inc.

510(k) K960272

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960272 Date2 Oct 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MLD
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Eagle 3000/3100 Patient Monitor is a Class II medical device designed for continuous monitoring of patient vital signs, including electrocardiogram (ECG) signals and ST-segment analysis with alarm capabilities. It provides real-time cardiac monitoring to support clinical decision-making in cardiovascular care settings.

This device is intended for use in hospital or clinical environments and is supplied as a reusable medical instrument. It operates in non-MRI environments and requires proper calibration and maintenance per manufacturer guidelines. Authorized under FDA 510(k) clearance (K960272), it adheres to regulatory standards for cardiovascular monitoring devices under 21 CFR 870.1025.

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Questions

AI-generated answers, 19 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 types of vital signs does the Eagle 3000/3100 Patient Monitor specifically track, and how does it support clinical decision-making in cardiovascular care?

    The Eagle 3000/3100 Patient Monitor continuously monitors electrocardiogram (ECG) signals and performs ST-segment analysis with integrated alarm capabilities. These features allow clinicians to detect early signs of cardiac issues, such as ischemia or arrhythmias, in real-time, directly supporting critical decision-making in cardiovascular care settings like hospitals.

  • Is the Eagle 3000/3100 designed for single-use or reusable applications, and what maintenance requirements should be followed?

    The device is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments. To ensure reliable performance, it requires proper calibration and maintenance as outlined by the manufacturer’s guidelines. Regular upkeep is essential for accuracy and safety in continuous patient monitoring.

  • Can this monitor be used in an MRI environment, and if not, what are the key limitations to consider?

    No, the Eagle 3000/3100 is not designed for MRI environments. The device is explicitly intended for use in non-MRI settings, so its placement near magnetic fields could compromise functionality or patient safety. Always verify the environment aligns with the manufacturer’s operational guidelines.

  • What regulatory pathway was followed for FDA clearance, and how does this affect its classification?

    The device was cleared through the FDA 510(k) pathway (K960272), classified as Substantially Equivalent (SESE) under the Cardiovascular (CV) advisory committee. It falls under Class II regulatory standards, specifically adhering to 21 CFR 870.1025 for cardiovascular monitoring devices, ensuring compliance with U.S. medical device regulations.