Cleared Traditional

K960272 - EAGLE 3000/3100 PATIENT MONITOR

K960272 is an FDA 510(k) clearance for EAGLE 3000/3100 PATIENT MONITOR, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K960272 · Marquette Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
258d
Days
Class 2
Risk

K960272 is an FDA 510(k) clearance for the EAGLE 3000/3100 PATIENT MONITOR. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 2, 1996 after a review of 258 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K960272

510(k) Number K960272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1996
Decision Date October 02, 1996
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 125d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MLD Monitor, St Segment With Alarm

All 12
Devices cleared under the same product code (MLD) and FDA review panel - the closest regulatory comparables to K960272.
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
K974492 · Siemens Medical Solutions USA, Inc. · Feb 1998
ACUITY CENTRAL STATION
K972121 · Protocol Systems, Inc. · Nov 1997
AS/3 ESTPR MODULE
K953175 · Datex Division Instrumentarium Corp. · Feb 1997
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
K960934 · Hewlett-Packard Co. · Jun 1996
MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
K920429 · Hewlett-Packard Co. · Jul 1993