Cleared Traditional

K964750 - EAGLE 4000 PATIENT MONITOR (FDA 510(k) Clearance)

K964750 · Marquette Electronics, Inc. · Cardiovascular device
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Feb 1997
Decision
87d
Days
-
Risk

K964750 is an FDA 510(k) clearance for the EAGLE 4000 PATIENT MONITOR.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 21, 1997 after a review of 87 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K964750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1996
Decision Date February 21, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -