Cleared Traditional

K960418 - EAGLE PATIENT MONITOR

K960418 is an FDA 510(k) clearance for EAGLE PATIENT MONITOR, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K960418 · Marquette Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
247d
Days
Class 2
Risk

K960418 is an FDA 510(k) clearance for the EAGLE PATIENT MONITOR. 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 October 2, 1996 after a review of 247 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 - K960418

510(k) Number K960418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date October 02, 1996
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 305
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K960418.
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
EAGLE PATIENT MONITOR MODEL 3000/3100
K961139 · Marquette Electronics, Inc. · Aug 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