Cleared Traditional

EAGLE PATIENT MONITOR MODEL 3000/3100 (K961139) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961139 · Marquette Electronics, Inc. · Cardiovascular device
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Aug 1996
Decision
141d
Days
Class 2
Risk

K961139 is an FDA 510(k) clearance for the EAGLE PATIENT MONITOR MODEL 3000/3100. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 9, 1996 after a review of 141 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K961139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date August 09, 1996
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K961139.
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404 · Siemens Medical Solutions USA, Inc. · Jan 1997
HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122 · Hewlett-Packard Co. · Jan 1997
HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A
K961165 · Hewlett-Packard Co. · Oct 1996
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K955743 · Siemens Medical Solutions USA, Inc. · Jul 1996
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
K952054 · Siemens Medical Solutions USA, Inc. · Jun 1996
OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
K955059 · Siemens Medical Solutions USA, Inc. · Jun 1996